Ultrasonic and electrosurgical devices

ABSTRACT

Disclosed are ultrasonic and electrosurgical devices. The disclosed embodiments include a surgical instrument comprising an ultrasonic waveguide including a proximal end and a distal end. The proximal end may be configured to couple to an ultrasonic transducer. The surgical instrument may comprise a first tube, and end effector, and an impedance mechanism. The first tube may define a lumen, wherein the waveguide is located within the lumen. The end effector may be coupled to the distal end of the waveguide. The end effector may comprise an ultrasonic blade and a clamp arm. The clamp arm is movable from a clamped position to a non-clamped position. The impedance mechanism may be configured to operatively couple to the end effector to prevent materials from accumulating within the lumen during a surgical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application claiming priority under 35U.S.C. §121 to U.S. patent application Ser. No. 13/843,295, entitledULTRASONIC AND ELECTROSURGICAL DEVICES, filed Mar. 15, 2013, now U.S.Patent Application Publication No. US 2014/0135804, which claims thebenefit of U.S. Provisional Patent Application Ser. No. 61/726,890,filed Nov. 15, 2012, entitled ULTRASONIC AND ELECTROSURGICAL DEVICES,the disclosures of which are hereby incorporated by reference in theirentirety.

INTRODUCTION

The present disclosure is related generally to ultrasonic and electricalsurgical devices. More particularly, the present disclosure is relatedto various blade features for ultrasonic blades to improve tissuegrasping, various seals and fluid egress features to prevent build upand accumulation of tissue and other bodily materials encountered duringsurgery on the distal portion of the tube(s) and the nearby portion ofthe blade of ultrasonic surgical devices, clamp closure mechanisms forultrasonic end effectors to provide uniform clamp force, rotationmechanisms for ultrasonic transducers and devices, and combinedelectrosurgical and ultrasonic devices to provide tissue cutting andspot coagulation.

Ultrasonic surgical devices, such as ultrasonic scalpels, are used inmany applications in surgical procedures by virtue of their uniqueperformance characteristics. Depending upon specific deviceconfigurations and operational parameters, ultrasonic surgical devicescan provide substantially simultaneous transection of tissue andhemostasis by coagulation, desirably minimizing patient trauma. Anultrasonic surgical device comprises a proximally-positioned ultrasonictransducer and an instrument coupled to the ultrasonic transducer havinga distally-mounted end effector comprising an ultrasonic blade to cutand seal tissue. The end effector is typically coupled either to ahandle and/or a robotic surgical implement via a shaft. The blade isacoustically coupled to the transducer via a waveguide extending throughthe shaft. Ultrasonic surgical devices of this nature can be configuredfor open surgical use, laparoscopic, or endoscopic surgical proceduresincluding robotic-assisted procedures.

Ultrasonic energy cuts and coagulates tissue using temperatures lowerthan those used in electrosurgical procedures. Vibrating at highfrequencies (e.g., 55,500 times per second), the ultrasonic bladedenatures protein in the tissue to form a sticky coagulum. Pressureexerted on tissue by the blade surface in combination with a clampingmechanism collapses blood vessels and allows the coagulum to form ahemostatic seal. A surgeon can control the cutting speed and coagulationby the force applied to the tissue by the end effector, the time overwhich the force is applied and the selected excursion level of the endeffector.

Also used in many surgical applications are electrosurgical devices.Electrosurgical devices apply electrical energy to tissue in order totreat tissue. An electrosurgical device may comprise an instrumenthaving a distally-mounted end effector comprising one or moreelectrodes. The end effector can be positioned against tissue such thatelectrical current is introduced into the tissue. Electrosurgicaldevices can be configured for bipolar or monopolar operation. Duringbipolar operation, current is introduced into and returned from thetissue by active and return electrodes, respectively, of the endeffector. During monopolar operation, current is introduced into thetissue by an active electrode of the end effector and returned through areturn electrode (e.g., a grounding pad) separately located on apatient's body. Heat generated by the current flow through the tissuemay form haemostatic seals within the tissue and/or between tissues andthus may be particularly useful for sealing blood vessels, for example.The end effector of an electrosurgical device sometimes also comprises acutting member that is movable relative to the tissue and the electrodesto transect the tissue.

Electrical energy applied by an electrosurgical device can betransmitted to the instrument by a generator. The electrical energy maybe in the form of radio frequency (“RF”) energy. RF energy is a form ofelectrical energy that may be in the frequency range of 300 kHz to 1MHz. During its operation, an electrosurgical device can transmit lowfrequency RF energy through tissue, which causes ionic agitation, orfriction, in effect resistive heating, thereby increasing thetemperature of the tissue. Because a sharp boundary may be createdbetween the affected tissue and the surrounding tissue, surgeons canoperate with a high level of precision and control, without sacrificingadjacent tissues or critical structures. The low operating temperaturesof RF energy may be useful for removing, shrinking, or sculpting softtissue while simultaneously sealing blood vessels. RF energy may workparticularly well on connective tissue, which is primarily comprised ofcollagen and shrinks when contacted by heat.

SUMMARY

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectorcoupled to the distal end of the waveguide; a tube comprising a lumen,wherein the waveguide is located within the lumen; a clamp arm pivotablyconnected to the tube; and a tissue accumulation impedance mechanismconfigured to prevent tissue from accumulating in the lumen.

In another embodiment of the ultrasonic surgical instrument, the tissueaccumulation impedance mechanism comprises a boot barrier configured tocreate a seal between the tube and the end effector.

In another embodiment of the ultrasonic surgical instrument, the bootbarrier is sealed to the tube using one or more retention features.

In another embodiment of the ultrasonic surgical instrument, the bootbarrier comprises a cavity.

In another embodiment of the ultrasonic surgical instrument, the cavityis rounded to allow fluid to flow out of the cavity.

In another embodiment of the ultrasonic surgical instrument, the bootbarrier comprises a plurality of contact points with the blade.

In another embodiment of the ultrasonic surgical instrument, the tissueaccumulation impedance mechanism comprises one or more apertures in thetube.

In another embodiment of the ultrasonic surgical instrument, theapertures comprise one or more windows.

In another embodiment of the ultrasonic surgical instrument theapertures comprise one or more holes.

In another embodiment of the ultrasonic surgical instrument, the distalportion comprises a hemispherical cross section.

In another embodiment of the ultrasonic surgical instrument, the tubecomprises one or more ribs formed on an inner side of the tube.

In another embodiment of the ultrasonic surgical instrument, the tissueaccumulation impedance mechanism comprises a pump configured to providea positive pressure flow between the blade and the tube, wherein thepositive pressure flow prevents tissue ingress into the lumen.

In another embodiment of the ultrasonic surgical instrument, the pump orthe outlet of the pump is located distally to a distal-most overmoldedseal located within the lumen.

In another embodiment of the ultrasonic surgical instrument the tissueaccumulation impedance mechanism comprises a slidable tube disposedwithin the lumen, the slidable tube slidable from a first position to asecond position, wherein in the first position the slidable tube isdisposed over the blade, and the second position the blade is exposed.

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectorcoupled to the distal end of the waveguide, the end effector comprisingat least one tissue retention feature; a clamp arm operatively coupledto the end effector.

In another embodiment of the ultrasonic surgical instrument, the atleast one tissue retention feature comprises one or moreindentations/grooves/notches/texture formed in the end effector.

In another embodiment of the ultrasonic surgical instrument, the one ormore indentations comprise triangular teeth.

In another embodiment of the ultrasonic surgical instrument, the one ormore indentations comprise holes.

In another embodiment of the ultrasonic surgical instrument, the one ormore indentations comprise horizontal trenches.

In another embodiment of the ultrasonic surgical instrument, the atleast on tissue retention feature comprises one or more projections fromthe end effector.

In another embodiment of the ultrasonic surgical instrument, the one ormore projections comprise triangular teeth.

In another embodiment of the ultrasonic surgical instrument, the one ormore projections comprise blocks.

In another embodiment of the ultrasonic surgical instrument, the one ormore projections comprise horizontal bumps.

In another embodiment of the ultrasonic surgical instrument, the one ormore projections comprise circular bumps.

In another embodiment of the ultrasonic surgical instrument, the atleast one tissue retention feature is disposed over an entire length ofthe blade.

In another embodiment of the ultrasonic surgical instrument, the atleast one tissue retention feature is disposed over a discrete sectionof the blade.

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectoroperatively coupled to the distal end of the waveguide guide; a rotationshroud configured to rotate the waveguide; and a rotation stop mechanismcoupled to the rotation shroud prevent rotation of the rotation knobbeyond a predetermined rotation.

In another embodiment of the ultrasonic surgical instrument, the shroudcomprises at least one channel; at least one boss, the at least one bosslocated within the at least one channel, wherein the at least one bosshas a predetermined lateral movement limit, wherein when the at leastone boss reaches the predetermined lateral movement limit, the at leastone boss prevents further rotation of the rotation knob.

In another embodiment of the ultrasonic surgical instrument, therotation stop comprises a gate comprising a first wing and a secondwing, wherein the first and second wings are disposed at an angle,wherein the gate is disposed within the shroud and the gate allows apredetermined angle of rotation of the shroud.

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectorcoupled to the distal end of the waveguide; a clamp arm operativelycoupled to the end effector; a tube disposed over the waveguide, whereinthe tube comprises a counter deflection element, wherein the counterdeflection element is configured to allow deflection of the blade,wherein the deflection of the blade counteracts a force placed on theblade by the clamp arm in a clamped position.

In one embodiment, a surgical instrument comprises a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to a signal source, the signal source configured to provide anultrasonic signal and an electrosurgical signal; an end effector coupledto the waveguide; a clamp arm operatively coupled to the end effector;and a sealing button, wherein the sealing button causes the surgicalinstrument to deliver the electrosurgical signal to the end effectorand/or the clamp arm for a first period and the sealing button causesthe surgical instrument to deliver the ultrasonic signal to the bladefor a second period, wherein the second period is subsequent to thefirst period.

In another embodiment of the surgical instrument, the sealing buttoncauses the surgical instrument to deliver the ultrasonic signal to theend effector prior to transmitting the electrosurgical signal to the endeffector and/or clamp arm.

In another embodiment of the surgical instrument, the sealing buttoncauses the surgical instrument to only deliver the ultrasonic signal tothe end effector resulting in haemostatic transection of tissue. Aseparate spot coagulation button is provided on the handle. When thespot coagulation button is depressed, an electrosurgical signal isprovided to either the end effector or the clamp arm or both to effectspot coagulation of tissue.

In another embodiment of the surgical instrument, wherein theelectrosurgical signal is a monopolar RF signal.

In another embodiment of the surgical instrument, wherein theelectrosurgical signal is a bipolar RF signal.

In one embodiment, a surgical instrument comprises a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to an ultrasonic transducer; an end effector coupled to thedistal end of the waveguide; a tube disposed over the waveguide; a camsurface formed on or in an outer surface of the tube; and a clamp arm,wherein the clamp arm is operatively coupled to the cam surface.

In another embodiment of the surgical instrument, a pivot pin is locatedwithin a hole defined by the end effector, the pivot pin operativelycoupled to the clamp arm, wherein the clamp arm pivots about the pivotpin.

In another embodiment of the surgical instrument, the pivot pin islocated at the distal most node of the waveguide.

In another embodiment of the surgical instrument, the tube is actuatableand the clamp arm is cammed open and closed against the end effectorthrough relative motion between the tube and the end effector.

In one embodiment, a surgical instrument comprises a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to an ultrasonic transducer; an end effector coupled to thedistal end of the waveguide, the end effector defining a pin hole; arigid pin disposed within the pin hole; a clamp arm operativelyconnected to the outer tube; and a four-bar linkage; wherein thefour-bar linkage is operatively coupled to the clamp arm and the rigidpin, wherein the four-bar linkage is actuatable via end effectortranslation to move the clamp arm to a clamped position.

In another embodiment of the surgical instrument, an outer tube iscoupled to the four-bar linkage and the outer-tube actuates the four-barlinkage from a first position to a second position.

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectorcoupled to the distal end of the waveguide, wherein the end effector ispartially coated with thermally and electrically insulative materialsuch that the distal end of the end effector comprises one or moreexposed sections.

In another embodiment of the ultrasonic surgical instrument endeffector, the one or more exposed areas are symmetrical.

In another embodiment of the ultrasonic surgical instrument endeffector, the one or more exposed areas are asymmetrical.

In another embodiment of the ultrasonic surgical instrument endeffector, the one or more exposed sections are separated by one or morecoated sections.

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectorcoupled to the distal end of the waveguide, and a clamp arm isoperatively connected to the end effector, wherein the clamp arm ispartially coated with thermally and electrically insulative materialsuch that the distal end of the clamp arm comprises one or more exposedsections.

In another embodiment of the ultrasonic surgical instrument clamp arm,the one or more exposed areas are symmetrical.

In another embodiment of the ultrasonic surgical instrument clamp arm,the one or more exposed areas are asymmetrical.

In another embodiment of the ultrasonic surgical instrument clamp arm,the one or more exposed sections are separated by one or more coatedsections.

In one embodiment, an ultrasonic surgical instrument comprises awaveguide comprising a proximal end and a distal end, wherein theproximal end is coupled to an ultrasonic transducer; an end effectorcoupled to the distal end of the waveguide, and a clamp arm isoperatively connected to the end effector, wherein the end effector andthe clamp arm are partially coated with thermally and electricallyinsulative material such that the distal end of the end effector andclamp arm comprise one or more exposed sections.

In another embodiment of the ultrasonic surgical instrument, the one ormore exposed areas are symmetrical.

In another embodiment of the ultrasonic surgical instrument, the one ormore exposed areas are asymmetrical.

In another embodiment of the ultrasonic surgical instrument, the one ormore exposed sections are separated by one or more coated sections.

The foregoing is a summary and thus may contain simplifications,generalizations, inclusions, and/or omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is NOT intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processes and/orother subject matter described herein will become apparent in theteachings set forth herein.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

FIGURES

The novel features of the embodiments described herein are set forthwith particularity in the appended claims. The embodiments, however,both as to organization and methods of operation may be betterunderstood by reference to the following description, taken inconjunction with the accompanying drawings as follows.

FIG. 1 illustrates one embodiment of an ultrasonic blade with tooth-likegrasping features formed on a grasping surface of the blade.

FIG. 2 illustrates one embodiment of the ultrasonic blade withtooth-like grasping features formed on a grasping portion of the blade,where the teeth are machined into the grasping portion of the blade.

FIG. 3 illustrates one embodiment of the ultrasonic blade withtooth-like grasping features formed on a grasping portion of the blade,where the teeth protrude from the grasping portion of the blade.

FIG. 4 illustrates one embodiment of an ultrasonic blade with protrudingblock-like grasping features formed on a grasping portion of the blade.

FIG. 5 is a side view of the ultrasonic blade shown in FIG. 4, accordingto one embodiment.

FIG. 6 illustrates one embodiment of an ultrasonic blade with protrudingbump-like or spike-like grasping features formed on a grasping portionof the blade.

FIG. 7A is a side view of the ultrasonic blade shown in FIG. 6,according to one embodiment.

FIG. 7B shows bump-like protrusions, according to one embodiment.

FIG. 7C shows spike-like protrusions, according to one embodiment.

FIG. 8 illustrates one embodiment of an ultrasonic blade withcavity-like grasping features formed on a grasping portion of the blade.

FIG. 9A is a side view of the ultrasonic blade shown in FIG. 8 havingcylindrical cavity-like grasping features partially formed into thegrasping portion of the blade, according to one embodiment.

FIG. 9B is a side view of the ultrasonic blade shown in FIG. 8 havingcylindrical cavity-like grasping features formed through the graspingportion of the blade, according to one embodiment.

FIG. 9C is a side view of the ultrasonic blade shown in FIG. 8 havingconical cavity-like grasping features partially formed into the graspingportion of the blade, according to one embodiment.

FIG. 10 illustrates one embodiment of an ultrasonic blade withtransverse bump-like grasping features formed on a grasping portion ofthe blade.

FIG. 11 is a side view of the ultrasonic blade shown in FIG. 10,according to one embodiment.

FIG. 12 is a side view of one embodiment of an end effector assemblycomprising medical forceps having a movable jaw member and an ultrasonicblade having protrusions in the form of tooth-like grasping featuresformed on a grasping surface of the blade.

FIG. 13 is a top view of one embodiment of the medical forceps shown inFIG. 12 with the movable jaw member drawn in phantom line to show theultrasonic blade positioned below the movable jaw member.

FIG. 14 is a side view illustrating one embodiment of an ultrasonicblade comprising tooth-like grasping features having triangular groovesformed on a grasping surface of the blade.

FIG. 15 is a top view of the ultrasonic blade shown in FIG. 14,according to one embodiment.

FIG. 16 is a side view illustrating one embodiment of an ultrasonicblade comprising tooth-like grasping features including horizontaltrenches having repeated semicircular grooves formed on a graspingsurface of the blade.

FIG. 17 is a top view of the ultrasonic blade shown in FIG. 16,according to one embodiment.

FIG. 18 is a top view illustrating one embodiment of an ultrasonic bladecomprising grasping features including cavities formed on a graspingsurface of the blade.

FIG. 19 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member and anultrasonic blade with a flexible seal positioned over a proximal portionof the blade and a distal portion of a tube to seal the blade to anouter diameter of the tube.

FIG. 20 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member and anultrasonic blade with a flexible seal positioned over a proximal portionof the blade and within a distal portion of a tube to seal the blade toan inner diameter of the tube.

FIG. 21 illustrates one embodiment of a slotted inner tube to conceal alengthwise portion of an ultrasonic blade where the slots provide fluidegress to discharge surgical matter that may accumulate in a spacebetween the blade and the inner tube.

FIG. 22 illustrates one embodiment of a perforated mutilated inner tubeto conceal a lengthwise portion of an ultrasonic blade where theperforations provide fluid egress to discharge surgical matter that mayaccumulate in a space between the blade and the inner tube.

FIG. 23 illustrates one embodiment of a fluid-directing ribbed andperforated inner tube to conceal a lengthwise portion of an ultrasonicblade where the fluid-directing ribs and perforations provide fluidegress to discharge surgical matter that may accumulate in a spacebetween the blade and the inner tube.

FIG. 24 is one embodiment of a fluid-directing ribbed and perforatedinner tube comprising converging ducts

FIG. 25 illustrates one embodiment of a contoured seal to seal a spacebetween a portion of an ultrasonic blade and an outer tube, where theflexible seal having two points of contact and defining a cavity forcollecting surgical matter.

FIG. 26 illustrates one embodiment of a hybrid system comprising acontoured seal comprising a flexible membrane that acts as a pump toforce surgical matter out of a distal inner tube area.

FIG. 27 illustrates one embodiment of a seal to seal a space between aportion of an ultrasonic blade and the tube, the flexible seal multiplepoints of contact and a low interference point of contact.

FIG. 28 illustrates etched areas formed on an outer surface of anultrasonic blade to prevent tissue ingress, according to one embodiment.

FIG. 29 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member and a slidableultrasonic blade partially retracted within a tube.

FIG. 30 illustrates one embodiment of an inner tube having machinedwindows formed therein to allow drainage between the inner and outertubes.

FIG. 31 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member and anultrasonic blade where the movable jaw member includes a pad with atissue stop to deflect surgical matter where the tissue stop portion iscontoured to the movable jaw member to cover an opening of the innertube.

FIG. 32 illustrates one embodiment of a positive pressure fluid flowsystem to apply a positive pressure fluid flow between an outer tube andan ultrasonic blade at distal end thereof employing a pump or pumpoutlet located distal of a distal node.

FIG. 33 illustrates a portion of an end effector assembly comprising anultrasonic blade including one embodiment of a flexible seal to seal theultrasonic blade to a tube at a distal node, according to oneembodiment.

FIG. 34 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member and anultrasonic blade including a flexible seal positioned distal to an edgeof the movable jaw member and anchored to a tube to prevent tissuepinching.

FIG. 35 illustrates one embodiment of a seal positioned within an innertube and an ultrasonic blade positioned within the inner tube.

FIG. 36 illustrates one embodiment of a seal mechanism for an ultrasonicblade having a tapered inner tube portion distal to the last seal wherethe inner tube necks down to a smaller diameter at a distal end defininga reduce entry space for surgical matter.

FIG. 37 illustrates one embodiment of an overmolded flexible seallocated over an inner tube that an ultrasonic blade punctures throughduring assembly.

FIG. 38 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member and anultrasonic blade where the movable jaw member comprises a deflector padto deflect surgical matter.

FIG. 39 is a front view of the deflector pad shown in FIG. 38, accordingto one embodiment.

FIG. 40 illustrates one embodiment of a seal system for an ultrasonicblade.

FIG. 41 illustrates one embodiment of a contoured inner tube orcomponent that attaches to an inner tube to provide a circuitous pathfor fluid.

FIG. 42 illustrates one embodiment of a molded component with compliantarms that serve to block the distal opening of a tube assembly and isattached via the arms going around a pin in the blade at a nodelocation.

FIG. 43 illustrates one embodiment of an overmolded silicone bumper thatadheres to the inside of an inner tube.

FIGS. 44-47 illustrate one embodiment of how a pair of mandrels can beinserted into an inner tube from both ends to form the overmolded bumperin FIG. 43.

FIG. 48 illustrates one embodiment of an overmolded material affixed toan inner tube that does not seal to the ultrasonic blade.

FIG. 49 illustrates one embodiment of a positive fluid pressure systemin which air is pumped down the length of the inner tube.

FIG. 50 illustrates one embodiment of an inner tube having a siliconeseal attached thereto at minimal interference with ultrasonic blade.

FIG. 51 illustrates one embodiment of seal system for sealing anultrasonic blade to a tube.

FIG. 52 illustrates one embodiment of a flexible seal located over aninner tube that an ultrasonic blade punctures through during assembly.

FIG. 53 illustrates one embodiment of an overmolded flexible sealattached to an ultrasonic blade distal of a distal seal.

FIG. 54 illustrates one embodiment of an overmolded flexible sealattached to an ultrasonic blade distal of a distal seal.

FIG. 55 illustrates one embodiment of a sealing system comprisingmultiple toroidal seals to seal an ultrasonic blade distal of a distalseal.

FIG. 56 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member in an openposition, an ultrasonic blade, and a slidably movable inner tubeincluding a wiping seal.

FIG. 57 illustrates one embodiment of the end effector assembly shown inFIG. 56 comprising a medical forceps having a movable jaw member in aclosed position.

FIG. 58 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member in an openposition shown in phantom line and a closed position shown in solidline, an ultrasonic blade, a slidably movable outer tube, and a fixedinner tube with a flexible seal located over the blade.

FIG. 59 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member in an openposition, an ultrasonic blade, a slidably movable outer tube, and afixed inner tube with a flexible seal overmolded on the inner tube.

FIG. 60 is a perspective view of one embodiment of an end effectorassembly comprising a medical forceps having a movable jaw member and anultrasonic blade where the movable jaw member is rotatably attached to adistal node.

FIG. 61 is a side view of one embodiment of the end effector assemblyshown in FIG. 60 with the movable jaw member in an open position andshown transparent to show outer tube cam slots to rotate the movable jawmember upon relative motion between the blade and the outer tube.

FIG. 62 illustrates one embodiment of the end effector assembly shown inFIG. 60 showing the movable jaw member pivot.

FIG. 63 is a side view of one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member in a closedposition and an ultrasonic blade, the end effector assembly comprising alinkage to open and close the movable jaw member by employing relativemotion between the outer tube and the blade.

FIG. 64 is a side view of the end effector assembly shown in FIG. 63with the movable jaw member in an open position, according to oneembodiment.

FIG. 65 is a bottom view of the end effector assembly shown in FIG. 63with the movable jaw member in an open position, according to oneembodiment.

FIG. 66 is a perspective view of the end effector assembly shown in FIG.63 with the movable jaw member in an open position, according to oneembodiment.

FIG. 67 is a perspective view of the end effector assembly shown in FIG.63 with the movable jaw member in an open position, according to oneembodiment.

FIG. 68 is a perspective view of one embodiment of an end effectorassembly comprising a medical forceps having a movable jaw member and anultrasonic blade with the movable jaw member shown in an open position,where an outer tube is translated with respect to the blade to open andclose the movable jaw member.

FIG. 69 is a perspective view of the inner tube with the outer tuberemoved, where the inner tube is operatively coupled to the end effectorassembly shown in FIG. 68, according to one embodiment.

FIG. 70 is a perspective view of a notch portion of the inner tube shownin FIG. 69, according to one embodiment.

FIG. 71 illustrates one embodiment of an end effector assemblycomprising a medical forceps having a movable jaw member in a closedposition, an ultrasonic blade, and a shaft assembly configured tocounteract deflection of the blade.

FIG. 72 illustrates one embodiment of an ultrasonic transducer having amodified flange incorporating external threads to allow transducerrotation.

FIG. 73 is a sectional view of one embodiment of an ultrasonictransducer rotation system comprising a shroud and a gate fitted intoone-half of the shroud.

FIGS. 74A-74C illustrate the dynamics of the gate interaction with arotation knob, according to one embodiment.

FIG. 74A illustrates the gate in a left-biased position such that therotation knob can be rotated approximately 690 degrees clockwise until acontoured extrusion element on the rotation knob makes contact with theright wing of the gate so that the left wing of the gate prevents motionby reacting statically against the shroud, according to one embodiment.

FIG. 74B illustrates the rotation knob rotated back 360° until it knocksthe right wing of the gate into a right-biased position, according toone embodiment.

FIG. 74C illustrates the rotation knob after it knocks the right wing ofthe gate into a right-biased position, according to one embodiment.

FIG. 75 is a sectional view of one embodiment of an ultrasonictransducer rotation system comprising a shroud and a gate fitted intoone-half of the shroud, where the rotation system comprises a tactilefeedback element.

FIGS. 76A-76C illustrate the dynamics of the gate interaction with arotation knob, where the rotation knob comprises a tactile feedbackelement, according to one embodiment.

FIG. 76A illustrates the gate in a left-biased position such that therotation knob comprising a tactile feedback element can be rotatedapproximately 690 degrees clockwise until a contoured extrusion elementon the rotation knob makes contact with the right wing of the gate sothat the left wing of the gate prevents motion by reacting staticallyagainst the shroud, according to one embodiment.

FIG. 76B illustrates the rotation knob comprising a tactile feedbackelement rotated back 360° until it knocks the right wing of the gateinto a right-biased position, according to one embodiment.

FIG. 76C illustrates the rotation knob comprising a tactile feedbackelement after it knocks the right wing of the gate into a right-biasedposition, according to one embodiment.

FIG. 77 illustrates one embodiment of an integrated RF/ultrasonicinstrument electrically connected such that the ultrasonic blade/horn iselectrically connected to a positive lead of an ultrasonic generatorcoupled to the instrument to provide RF spot coagulation. The clamp armand tube are connected to the return path.

FIG. 78 illustrates one embodiment of an integrated RF/ultrasonicinstrument comprising four-lead jack connector mated with a slidablefemale mating plug electrically connected to a generator.

FIG. 79 is a detail view of one embodiment of a four-lead jack connectormated with a slidable female mating plug coupled to an ultrasonictransducer where position 1 provides an ultrasonic signal to thetransducer, and where position 2 provides an electrosurgical signal tothe device.

FIGS. 80-83 illustrate various embodiments of ultrasonic blades coatedwith an electrically insulative material to provide thermal insulationat the tissue contact area to minimize adhesion of tissue to the blade.

FIGS. 84-93 illustrate various embodiments of ultrasonic bladespartially coated with an electrically insulative material to providethermal insulation at the tissue contact area to minimize adhesion oftissue to the blade, where the lighter shade regions of the bladerepresent the coated portions and the darker shaded regions of the bladerepresent exposed surfaces that enable RF current to flow from theexposed region of the blade, through the tissue, and the movable jawmember. It is conceivable that this feature may be employed on theblade, the clamp arm, or both.

FIGS. 94-95 illustrate embodiments of two ultrasonic blades withnon-symmetrical exposed surface, where the blades are coated with anelectrically insulative material to provide thermal insulation at thetissue contact area to minimize adhesion of tissue to the blade, wherethe lighter shade regions of the blade represent the coated portions andthe darker shaded regions of the blade represent exposed surfaces thatenable RF current to flow from the exposed region of the blade, throughthe tissue, and the movable jaw member. It is conceivable that thisfeature may be employed on the blade, the clamp arm, or both.

FIG. 96 is a perspective view of one embodiment of an ultrasonic endeffector comprising a metal heat shield.

FIG. 97 is a perspective view of another embodiment of an ultrasonic endeffector comprising a retractable metal heat shield.

FIG. 98 is a side view of another embodiment of an ultrasonic endeffector comprising a heat shield shown in cross-section.

FIG. 99 is a front view of the ultrasonic end effector shown in FIG. 98,according to one embodiment.

FIG. 100 illustrates one embodiment of a clamp arm comprising a movablejaw member shown in a closed position and a dual purpose rotatable heatshield located below the ultrasonic blade.

FIG. 101 illustrates one embodiment of a movable jaw member shown in anopen position and a dual purpose rotatable heat shield rotated such thatit is interposed between the movable jaw member and the blade.

FIG. 102 illustrates an end view of one embodiment of a dual purposerotatable heat shield rotated in a first position.

FIG. 103 illustrates an end view of one embodiment of the dual purposerotatable heat shield rotated in a second position.

FIG. 104 is a top profile view of one embodiment of a heat shieldshowing a tapered portion of the shield.

FIG. 105 illustrates a conventional rongeur surgical instrument.

FIG. 106 illustrates one embodiment of an ultrasonic energy drivenrongeur device.

FIG. 107 illustrates one embodiment of a surgical system including asurgical instrument and an ultrasonic generator.

FIG. 108 illustrates one embodiment of the surgical instrument shown inFIG. 107.

FIG. 109 illustrates one embodiment of an ultrasonic end effector.

FIG. 110 illustrates another embodiment of an ultrasonic end effector.

FIG. 111 illustrates an exploded view of one embodiment of the surgicalinstrument shown in FIG. 107.

FIGS. 112A and 112B illustrate one embodiment of an unlimited rotationconnection for an integrated transducer

FIGS. 113A-113C illustrate one embodiment of an unlimited rotationconnection for an integrated transducer.

FIGS. 114A and 114B illustrate one embodiment of an integratedRF/ultrasonic surgical end effector.

FIGS. 115A-115I illustrate various electrode arrangements for theintegrated RF/ultrasonic surgical end effector of FIGS. 114A and 114B.

FIG. 116A illustrates one embodiment of an air cooled surgicalinstrument.

FIG. 116B illustrates one embodiment of a vortex tube.

FIG. 117 illustrates one embodiment of an integrated RF/ultrasonicsurgical instrument comprising a double pole double throw switch.

FIG. 118 illustrates one embodiment of a double pole double throwswitch.

FIGS. 119A-119E illustrate various embodiments of combinationRF/ultrasonic end effectors.

FIGS. 120A-120C illustrate various embodiments of bipolar combinationRF/ultrasonic end effectors.

FIGS. 121A-121C illustrate various embodiments of monopolar combinationRF/ultrasonic end effectors.

DESCRIPTION

Before explaining the various embodiments of the ultrasonic andelectrical surgical devices in detail, it should be noted that thevarious embodiments disclosed herein are not limited in theirapplication or use to the details of construction and arrangement ofparts illustrated in the accompanying drawings and description. Rather,the disclosed embodiments are may be positioned or incorporated in otherembodiments, variations and modifications thereof, and may be practicedor carried out in various ways. Accordingly, embodiments of theultrasonic and electrical surgical devices disclosed herein areillustrative in nature and are not meant to limit the scope orapplication thereof. Furthermore, unless otherwise indicated, the termsand expressions employed herein have been chosen for the purpose ofdescribing the embodiments for the convenience of the reader and are notto limit the scope thereof. In addition, it should be understood thatany one or more of the disclosed embodiments, expressions ofembodiments, and/or examples thereof, can be combined with any one ormore of the other disclosed embodiments, expressions of embodiments,and/or examples thereof, without limitation.

In the following description, like reference characters designate likeor corresponding parts throughout the several views. Also, in thefollowing description, it is to be understood that terms such as front,back, inside, outside, top, bottom and the like are words of convenienceand are not to be construed as limiting terms. Terminology used hereinis not meant to be limiting insofar as devices described herein, orportions thereof, may be attached or utilized in other orientations. Thevarious embodiments will be described in more detail with reference tothe drawings.

In various embodiments, the present disclosure is related to variousembodiments of ultrasonic blades comprising various grasping features.Conventional ultrasonic blades lack grasping features. Such graspingfeatures may be desirable on a gripping surface of an ultrasonic bladeto provide additional gripping and to prevent tissue milking duringgrasping and treatment, which in some cases may improve hemostasis.Tissue milking occurs when a tissue section slides, or milks, out of thejaws of a surgical device during treatment. The present disclosureprovides various blade modification features to prevent tissue milking,as well as provide better grasping forces.

In various embodiments, the present disclosure is related to variousembodiments of devices configured to prevent ingress of surgical matter,e.g., fluid and tissue, in the space between an ultrasonic blade and aninner or outer tube distal of the distal seal. Two main categories ofembodiments are described. First, a pressure or energy source attachedto the blade-tube subassembly prevents fluid or tissue ingress into thespace between the blade and the inner tube. Second, a flexiblemembrane(s) attached to either the blade or the inner tube preventsfluid or tissue ingress.

In various embodiments, the present disclosure also is related tovarious embodiments of alternate closure mechanisms for ultrasonicdevices. Present ultrasonic devices utilize a tube-in-tube (TnT) closuremechanism to enable closure of the clamp arm, referred to herein as amovable jaw member, against an active length of the ultrasonic blade.The present embodiments of alternate closure mechanisms for ultrasonicdevices may yield several advantages. For example, there may bedifferences among the drag force of actuating the inner tube against theouter tube resulting in variation in device clamp force. Additionally,the pivot location of the clamp arm on the outer tube causes a sharpangular closure, and results in a non-uniform closure profile.Furthermore, present device mechanism may be sensitive to variation incomponents, as the stackup links the inner and outer tube at thelocation of the insulated pin, which currently resides near the proximalend of the tube assembly.

In various embodiments, the present disclosure also is related tovarious embodiments of shaft assembly/transducer rotation limiters tolimit the rotation of the shaft and ultrasonic transducer.

In various embodiments, the present disclosure also is related tovarious embodiments of shaft/ultrasonic transducer rotation systems toprovide unlimited continuous rotation of an ultrasonic device. Invarious embodiments, tactile feedback may be provided to the user beforea hard stop is hit.

In various embodiments, the present disclosure also is related tovarious embodiments of an integrated RF/ultrasonic instrumentelectrically connected to provide RF spot coagulation energy for pre- orpost-ultrasonic treatment of tissues with an ultrasonic/RF generator.The integrated ultrasonic instrument enables the touch up of diffusebleeding (capillary bleeding, cut site oozing) or pre-treatment oftissue without the need for coupling pressure and improves the couplingpressure needed for ultrasonic instruments to couple the blade to tissuesuch that friction-based tissue effect is effective. The integratedultrasonic instrument reduces (1) difficulty in applying enough pressureto generate haemostatic effect in loosely supported (i.e., un-clamped)tissue or (2) coupling pressure that generates too much tissuedisruption that, in many cases, makes the diffuse bleeding worse. In oneembodiment, a four-lead jack connector is mated with a slidable femalemating plug to electrically isolate a secondary RF generator from theultrasonic transducer when switching between RF energy and ultrasonicenergy.

In various embodiments, the present disclosure is also directed toultrasonic blades comprising heat shields. The heat shields may befixed, translatable or rotatable. The heat shield also may be used toconduct RF energy to target tissue.

In various embodiments, the present disclosure also is related to coatedultrasonic/RF blades. Ultrasonic blades are coated with an electricallyinsulative material to provide thermal insulation at the tissue contactarea to minimize adhesion of tissue to the blade. Conventionalultrasonic devices utilize one mode of treatment, which limitsversatility. For example, conventional ultrasonic devices may be usedfor blood vessel sealing and transecting tissue. Bipolar or monopolar RFmay offer added benefits such as a method for spot coagulation andpretreatment of tissue. Incorporating ultrasonic and RF may provideversatility and increase effectiveness. However, conventional ultrasonicdevices utilize coatings to provide reduced friction and thermalinsulation at the distal end of the blade. These coatings areelectrically insulative, and therefore limit current flow thusdecreasing RF effectiveness. Additionally, current density may influenceeffectiveness. In order to incorporate both modes into one device, amasking or selective coating removal process may be required. Creatingan exposed area on the surface of the blade may provide a suitable pathfor current flow. It is conceivable that the same principles may beapplied to the clamping member as well.

General Surgical Instrument Overview

Before launching into a description of various embodiments, the presentdisclosures turns to the description of FIGS. 107-111, which describesvarious embodiments of a surgical system in which various embodiments ofthe ultrasonic and electrical surgical devices described in connectionwith FIGS. 1-106 may be practiced. Accordingly, FIG. 107 is a right sideview of one embodiment of an ultrasonic surgical instrument 10. In theillustrated embodiment, the ultrasonic surgical instrument 10 may beemployed in various surgical procedures including laparoscopic,endoscopic or traditional open surgical procedures. In one exampleembodiment, the ultrasonic surgical instrument 10 comprises a handleassembly 12, an elongated shaft assembly 14, and an ultrasonictransducer 16. The handle assembly 12 comprises a trigger assembly 24, adistal rotation assembly 13, and an activation switch assembly 28. Theelongated shaft assembly 14 comprises an end effector assembly 26, whichcomprises elements to dissect tissue or mutually grasp, cut, andcoagulate vessels and/or tissue, and actuating elements to actuate theend effector assembly 26. The handle assembly 12 is adapted to receivethe ultrasonic transducer 16 at the proximal end. The ultrasonictransducer 16 is mechanically engaged to the elongated shaft assembly 14and portions of the end effector assembly 26. The ultrasonic transducer16 is electrically coupled to a generator 20 via a cable 22. Althoughthe majority of the drawings depict a multiple end effector assembly 26for use in connection with laparoscopic surgical procedures, theultrasonic surgical instrument 10 may be employed in more traditionalopen surgical procedures and in other embodiments, may be configured foruse in laparoscopic or endoscopic procedures. For the purposes herein,the ultrasonic surgical instrument 10 is described in terms of anlaparoscopic instrument; however, it is contemplated that an open and/orendoscopic version of the ultrasonic surgical instrument 10 also mayinclude the same or similar operating components and features asdescribed herein.

In various embodiments, the generator 20 comprises several functionalelements, such as modules and/or blocks. Different functional elementsor modules may be configured for driving different kinds of surgicaldevices. For example, an ultrasonic generator module 21 may drive anultrasonic device, such as the ultrasonic surgical instrument 10. Insome example embodiments, the generator 20 also comprises anelectrosurgery/RF generator module 23 for driving an electrosurgicaldevice (or an electrosurgical embodiment of the ultrasonic surgicalinstrument 10). In various embodiments, the generator 20 may be formedintegrally within the handle assembly 12. In such implementations, abattery would be co-located within the handle assembly 12 to act as theenergy source.

In some embodiments, the electrosurgery/RF generator module 23 may beconfigured to generate a therapeutic and/or a sub-therapeutic energylevel. In the example embodiment illustrated in FIG. 107, the generator20 includes a control system 25 integral with the generator 20, and afoot switch 29 connected to the generator via a cable 27. The generator20 may also comprise a triggering mechanism for activating a surgicalinstrument, such as the instrument 10. The triggering mechanism mayinclude a power switch (not shown) as well as a foot switch 29. Whenactivated by the foot switch 29, the generator 20 may provide energy todrive the acoustic assembly of the surgical instrument 10 and to drivethe end effector 18 at a predetermined excursion level or provide thetherapeutic/sub-therapeutic electromagnetic/RF energy. The generator 20drives or excites the acoustic assembly at any suitable resonantfrequency of the acoustic assembly and/or drives thetherapeutic/sub-therapeutic electromagnetic/RF energy.

In one embodiment, the electrosurgical/RF generator module 23 may beimplemented as an electrosurgery unit (ESU) capable of supplying powersufficient to perform bipolar electrosurgery using RF energy. In oneembodiment, the ESU can be a bipolar ERBE ICC 350 sold by ERBE USA, Inc.of Marietta, Ga. In bipolar electrosurgery applications, as previouslydiscussed, a surgical instrument having an active electrode and a returnelectrode can be utilized, wherein the active electrode and the returnelectrode can be positioned against, or adjacent to, the tissue to betreated such that current can flow from the active electrode to thereturn electrode through the tissue. Accordingly, the electrosurgical/RFmodule 23 generator may be configured for therapeutic purposes byapplying electrical energy to the tissue T sufficient for treating thetissue (e.g., cauterization).

In one embodiment, the electrosurgical/RF generator module 23 may beconfigured to deliver a sub-therapeutic RF signal to implement a tissueimpedance measurement module. In one embodiment, the electrosurgical/RFgenerator module 23 comprises a bipolar RF generator as described inmore detail below. In one embodiment, the electrosurgical/RF generatormodule 12 may be configured to monitor electrical impedance Z, of tissueT and to control the characteristics of time and power level based onthe tissue T by way of a return electrode on provided on a clamp memberof the end effector assembly 26. Accordingly, the electrosurgical/RFgenerator module 23 may be configured for sub-therapeutic purposes formeasuring the impedance or other electrical characteristics of thetissue T. Techniques and circuit configurations for measuring theimpedance or other electrical characteristics of tissue T are discussedin more detail in commonly assigned U.S. Patent Publication No.2011/0015631, titled “Electrosurgical Generator for Ultrasonic SurgicalInstruments,” the disclosure of which is herein incorporated byreference in its entirety.

A suitable ultrasonic generator module 21 may be configured tofunctionally operate in a manner similar to the GEN300 sold by EthiconEndo-Surgery, Inc. of Cincinnati, Ohio as is disclosed in one or more ofthe following U.S. patents, all of which are incorporated by referenceherein: U.S. Pat. No. 6,480,796 (Method for Improving the Start Up of anUltrasonic System Under Zero Load Conditions); U.S. Pat. No. 6,537,291(Method for Detecting Blade Breakage Using Rate and/or ImpedanceInformation); U.S. Pat. No. 6,662,127 (Method for Detecting Presence ofa Blade in an Ultrasonic System); U.S. Pat. No. 6,678,899 (Method forDetecting Transverse Vibrations in an Ultrasonic Surgical System); U.S.Pat. No. 6,977,495 (Detection Circuitry for Surgical Handpiece System);U.S. Pat. No. 7,077,853 (Method for Calculating Transducer Capacitanceto Determine Transducer Temperature); U.S. Pat. No. 7,179,271 (Methodfor Driving an Ultrasonic System to Improve Acquisition of BladeResonance Frequency at Startup); and U.S. Pat. No. 7,273,483 (Apparatusand Method for Alerting Generator Function in an Ultrasonic SurgicalSystem).

It will be appreciated that in various embodiments, the generator 20 maybe configured to operate in several modes. In one mode, the generator 20may be configured such that the ultrasonic generator module 21 and theelectrosurgical/RF generator module 23 may be operated independently.Alternatively, the ultrasonic generator module 21 may be configured toselectively apply either ultrasonic energy or either therapeuticsub-therapeutic RF energy to the end effector.

For example, the ultrasonic generator module 21 may be activated toapply ultrasonic energy to the end effector assembly 26 andsubsequently, either therapeutic sub-therapeutic RF energy may beapplied to the end effector assembly 26 by the electrosurgical/RFgenerator module 23. As previously discussed, the subtherapeuticelectrosurgical/RF energy may be applied to tissue clamped between clampelements of the end effector assembly 26 to measure tissue impedance tocontrol the activation, or modify the activation, of the ultrasonicgenerator module 21. Tissue impedance feedback from the application ofthe subtherapeutic energy also may be employed to activate a therapeuticlevel of the electrosurgical/RF generator module 23 to seal the tissue(e.g., vessel) clamped between claim elements of the end effectorassembly 26.

In another embodiment, the ultrasonic generator module 21 and theelectrosurgical/RF generator module 23 may be activated simultaneously.In one example, the ultrasonic generator module 21 is simultaneouslyactivated with a sub-therapeutic RF energy level to measure tissueimpedance simultaneously while the ultrasonic blade of the end effectorassembly 26 cuts and coagulates the tissue (or vessel) clamped betweenthe clamp elements of the end effector assembly 26. Such feedback may beemployed, for example, to modify the drive output of the ultrasonicgenerator module 21. In another example, the ultrasonic generator module21 may be driven simultaneously with electrosurgical/RF generator module23 such that the ultrasonic blade portion of the end effector assembly26 is employed for cutting the damaged tissue while theelectrosurgical/RF energy is applied to electrode portions of the endeffector clamp assembly 26 for sealing the tissue (or vessel).Alternatively, the ultrasonic and the electrosurgical/RF energy can beemployed sequentially with a single activation to achieve a desiredtissue effect.

When the generator 20 is activated via the triggering mechanism, in oneembodiment electrical energy is continuously applied by the generator 20to a transducer stack or assembly of the acoustic assembly. In anotherembodiment, electrical energy is intermittently applied (e.g., pulsed)by the generator 20. A phase-locked loop in the control system of thegenerator 20 may monitor feedback from the acoustic assembly. The phaselock loop adjusts the frequency of the electrical energy sent by thegenerator 20 to match the resonant frequency of the selectedlongitudinal mode of vibration of the acoustic assembly. In addition, asecond feedback loop in the control system 25 maintains the electricalcurrent supplied to the acoustic assembly at a pre-selected constantlevel in order to achieve substantially constant excursion at the endeffector 18 of the acoustic assembly. In yet another embodiment, a thirdfeedback loop in the control system 25 monitors impedance betweenelectrodes located in the end effector assembly 26. Although FIGS.107-111 show a manually operated ultrasonic surgical instrument, it willbe appreciated that ultrasonic surgical instruments may also be used inrobotic applications, for example, as described herein, as well ascombinations of manual and robotic applications.

In ultrasonic operation mode, the electrical signal supplied to theacoustic assembly may cause the distal end of the end effector 18 tovibrate longitudinally in the range of, for example, approximately 20kHz to 250 kHz. According to various embodiments, the blade 22 mayvibrate in the range of about 40 kHz to 56 kHz, for example, at about50.0 kHz. In other embodiments, the blade 22 may vibrate at otherfrequencies including, for example, about 31 kHz or about 80 kHz. Theexcursion of the vibrations at the blade can be controlled by, forexample, controlling the amplitude of the electrical signal applied tothe transducer assembly of the acoustic assembly by the generator 20. Asnoted above, the triggering mechanism of the generator 20 allows a userto activate the generator 20 so that electrical energy may becontinuously or intermittently supplied to the acoustic assembly. Thegenerator 20 also has a power line for insertion in an electro-surgicalunit or conventional electrical outlet. It is contemplated that thegenerator 20 can also be powered by a direct current (DC) source, suchas a battery. The generator 20 can comprise any suitable generator, suchas Model No. GEN04, and/or Model No. GEN11 available from EthiconEndo-Surgery, Inc.

FIG. 108 is a left perspective view of one example embodiment of theultrasonic surgical instrument 10 showing the handle assembly 12, thedistal rotation assembly 13, the elongated shaft assembly 14, and theend effector assembly 26. In the illustrated embodiment the elongatedshaft assembly 14 comprises a distal end 52 dimensioned to mechanicallyengage the end effector assembly 26 and a proximal end 50 thatmechanically engages the handle assembly 12 and the distal rotationassembly 13. The proximal end 50 of the elongated shaft assembly 14 isreceived within the handle assembly 12 and the distal rotation assembly13. More details relating to the connections between the elongated shaftassembly 14, the handle assembly 12, and the distal rotation assembly 13are provided in the description of FIG. 98.

In the illustrated embodiment, the trigger assembly 24 comprises atrigger 32 that operates in conjunction with a fixed handle 34. Thefixed handle 34 and the trigger 32 are ergonomically formed and adaptedto interface comfortably with the user. The fixed handle 34 isintegrally associated with the handle assembly 12. The trigger 32 ispivotally movable relative to the fixed handle 34 as explained in moredetail below with respect to the operation of the ultrasonic surgicalinstrument 10. The trigger 32 is pivotally movable in direction 33Atoward the fixed handle 34 when the user applies a squeezing forceagainst the trigger 32. A spring element 98 (FIG. 111) causes thetrigger 32 to pivotally move in direction 33B when the user releases thesqueezing force against the trigger 32.

In one example embodiment, the trigger 32 comprises an elongated triggerhook 36, which defines an aperture 38 between the elongated trigger hook36 and the trigger 32. The aperture 38 is suitably sized to receive oneor multiple fingers of the user therethrough. The trigger 32 also maycomprise a resilient portion 32 a molded over the trigger 32 substrate.The overmolded resilient portion 32 a is formed to provide a morecomfortable contact surface for control of the trigger 32 in outwarddirection 33B. In one example embodiment, the overmolded resilientportion 32 a may be provided over a portion of the elongated triggerhook 36. The proximal surface of the elongated trigger hook 32 remainsuncoated or coated with a non-resilient substrate to enable the user toeasily slide their fingers in and out of the aperture 38. In anotherembodiment, the geometry of the trigger forms a fully closed loop whichdefines an aperture suitably sized to receive one or multiple fingers ofthe user therethrough. The fully closed loop trigger also may comprise aresilient portion molded over the trigger substrate.

In one example embodiment, the fixed handle 34 comprises a proximalcontact surface 40 and a grip anchor or saddle surface 42. The saddlesurface 42 rests on the web where the thumb and the index finger arejoined on the hand. The proximal contact surface 40 has a pistol gripcontour that receives the palm of the hand in a normal pistol grip withno rings or apertures. The profile curve of the proximal contact surface40 may be contoured to accommodate or receive the palm of the hand. Astabilization tail 44 is located towards a more proximal portion of thehandle assembly 12. The stabilization tail 44 may be in contact with theuppermost web portion of the hand located between the thumb and theindex finger to stabilize the handle assembly 12 and make the handleassembly 12 more controllable.

In one example embodiment, the switch assembly 28 may comprise a toggleswitch 30. The toggle switch 30 may be implemented as a single componentwith a central pivot 304 located within inside the handle assembly 12 toeliminate the possibility of simultaneous activation. In one exampleembodiment, the toggle switch 30 comprises a first projecting knob 30 aand a second projecting knob 30 b to set the power setting of theultrasonic transducer 16 between a minimum power level (e.g., MIN) and amaximum power level (e.g., MAX). In another embodiment, the rockerswitch may pivot between a standard setting and a special setting. Thespecial setting provides one or more special programs to be implementedby the device. The toggle switch 30 rotates about the central pivot asthe first projecting knob 30 a and the second projecting knob 30 b areactuated. The one or more projecting knobs 30 a, 30 b are coupled to oneor more arms that move through a small arc and cause electrical contactsto close or open an electric circuit to electrically energize orde-energize the ultrasonic transducer 16 in accordance with theactivation of the first or second projecting knobs 30 a, 30 b. Thetoggle switch 30 is coupled to the generator 20 to control theactivation of the ultrasonic transducer 16. The toggle switch 30comprises one or more electrical power setting switches to activate theultrasonic transducer 16 to set one or more power settings for theultrasonic transducer 16. The forces required to activate the toggleswitch 30 are directed substantially toward the saddle point 42, thusavoiding any tendency of the instrument to rotate in the hand when thetoggle switch 30 is activated.

In one example embodiment, the first and second projecting knobs 30 a,30 b are located on the distal end of the handle assembly 12 such thatthey can be easily accessible by the user to activate the power withminimal, or substantially no, repositioning of the hand grip, making itsuitable to maintain control and keep attention focused on the surgicalsite (e.g., a monitor in a laparoscopic procedure) while activating thetoggle switch 30. The projecting knobs 30 a, 30 b may be configured towrap around the side of the handle assembly 12 to some extent to be moreeasily accessible by variable finger lengths and to allow greaterfreedom of access to activation in awkward positions or for shorterfingers.

In the illustrated embodiment, the first projecting knob 30 a comprisesa plurality of tactile elements 30 c, e.g., textured projections or“bumps” in the illustrated embodiment, to allow the user todifferentiate the first projecting knob 30 a from the second projectingknob 30 b. It will be appreciated by those skilled in the art thatseveral ergonomic features may be incorporated into the handle assembly12. Such ergonomic features are described in U.S. Pat. App. Pub. No.2009/055750 entitled “Ergonomic Surgical Instruments” which isincorporated by reference herein in its entirety.

In one example embodiment, the toggle switch 30 may be operated by thehand of the user. The user may easily access the first and secondprojecting knobs 30 a, 30 b at any point while also avoiding inadvertentor unintentional activation at any time. The toggle switch 30 mayreadily operated with a finger to control the power to the ultrasonicassembly 16 and/or to the ultrasonic assembly 16. For example, the indexfinger may be employed to activate the first contact portion 30 a toturn on the ultrasonic assembly 16 to a maximum (MAX) power level. Theindex finger may be employed to activate the second contact portion 30 bto turn on the ultrasonic assembly 16 to a minimum (MIN) power level. Inanother embodiment, the rocker switch may pivot the instrument 10between a standard setting and a special setting. The special settingprovides one or more special programs to be implemented by theinstrument 10. The toggle switch 30 may be operated without the userhaving to look at the first or second projecting knob 30 a, 30 b. Forexample, the first projecting knob 30 a or the second projecting knob 30b may comprise a texture or projections to tactilely differentiatebetween the first and second projecting knobs 30 a, 30 b withoutlooking.

In other embodiments, the trigger 32 and/or the toggle switch 30 may beemployed to actuate the electrosurgical/RF generator module 23individually or in combination with activation of the ultrasonicgenerator module 21.

In one example embodiment, the distal rotation assembly 13 is rotatablewithout limitation in either direction about a longitudinal axis “T.”The distal rotation assembly 13 is mechanically engaged to the elongatedshaft assembly 14. The distal rotation assembly 13 is located on adistal end of the handle assembly 12. The distal rotation assembly 13comprises a cylindrical hub 46 and a rotation knob 48 formed over thehub 46. The hub 46 mechanically engages the elongated shaft assembly 14.The rotation knob 48 may comprise fluted polymeric features and may beengaged by a finger (e.g., an index finger) to rotate the elongatedshaft assembly 14. The hub 46 may comprise a material molded over theprimary structure to form the rotation knob 48. The rotation knob 48 maybe overmolded over the hub 46. The hub 46 comprises an end cap portion46 a that is exposed at the distal end. The end cap portion 46 a of thehub 46 may contact the surface of a trocar during laparoscopicprocedures. The hub 46 may be formed of a hard durable plastic such aspolycarbonate to alleviate any friction that may occur between the endcap portion 46 a and the trocar. The rotation knob 48 may comprise“scallops” or flutes formed of raised ribs 48 a and concave portions 48b located between the ribs 48 a to provide a more precise rotationalgrip. In one example embodiment, the rotation knob 48 may comprise aplurality of flutes (e.g., three or more flutes). In other embodiments,any suitable number of flutes may be employed. The rotation knob 48 maybe formed of a softer polymeric material overmolded onto the hardplastic material. For example, the rotation knob 48 may be formed ofpliable, resilient, flexible polymeric materials including Versaflex®TPE alloys made by GLS Corporation, for example. This softer overmoldedmaterial may provide a greater grip and more precise control of themovement of the rotation knob 48. It will be appreciated that anymaterials that provide adequate resistance to sterilization, arebiocompatible, and provide adequate frictional resistance to surgicalgloves may be employed to form the rotation knob 48.

In one example embodiment, the handle assembly 12 is formed from two (2)housing portions or shrouds comprising a first portion 12 a and a secondportion 12 b. From the perspective of a user viewing the handle assembly12 from the distal end towards the proximal end, the first portion 12 ais considered the right portion and the second portion 12 b isconsidered the left portion. Each of the first and second portions 12 a,12 b includes a plurality of interfaces 69 (FIG. 111) dimensioned tomechanically align and engage each another to form the handle assembly12 and enclosing the internal working components thereof. The fixedhandle 34, which is integrally associated with the handle assembly 12,takes shape upon the assembly of the first and second portions 12 a and12 b of the handle assembly 12. A plurality of additional interfaces(not shown) may be disposed at various points around the periphery ofthe first and second portions 12 a and 12 b of the handle assembly 12for ultrasonic welding purposes, e.g., energy direction/deflectionpoints. The first and second portions 12 a and 12 b (as well as theother components described below) may be assembled together in anyfashion known in the art. For example, alignment pins, snap-likeinterfaces, tongue and groove interfaces, locking tabs, adhesive ports,may all be utilized either alone or in combination for assemblypurposes.

In one example embodiment, the elongated shaft assembly 14 comprises aproximal end 50 adapted to mechanically engage the handle assembly 12and the distal rotation assembly 13; and a distal end 52 adapted tomechanically engage the end effector assembly 26. The elongated shaftassembly 14 comprises an outer tubular sheath 56 and a reciprocatingtubular actuating member 58 located within the outer tubular sheath 56.The proximal end of the tubular reciprocating tubular actuating member58 is mechanically engaged to the trigger 32 of the handle assembly 12to move in either direction 60A or 60B in response to the actuationand/or release of the trigger 32. The pivotably moveable trigger 32 maygenerate reciprocating motion along the longitudinal axis “T.” Suchmotion may be used, for example, to actuate the jaws or clampingmechanism of the end effector assembly 26. A series of linkagestranslate the pivotal rotation of the trigger 32 to axial movement of ayoke coupled to an actuation mechanism, which controls the opening andclosing of the jaws of the clamping mechanism of the end effectorassembly 26. The distal end of the tubular reciprocating tubularactuating member 58 is mechanically engaged to the end effector assembly26. In the illustrated embodiment, the distal end of the tubularreciprocating tubular actuating member 58 is mechanically engaged to aclamp arm assembly 64, which is pivotable about a pivot point 70, toopen and close the clamp arm assembly 64 in response to the actuationand/or release of the trigger 32. For example, in the illustratedembodiment, the clamp arm assembly 64 is movable in direction 62A froman open position to a closed position about a pivot point 70 when thetrigger 32 is squeezed in direction 33A. The clamp arm assembly 64 ismovable in direction 62B from a closed position to an open positionabout the pivot point 70 when the trigger 32 is released or outwardlycontacted in direction 33B.

In one example embodiment, the end effector assembly 26 is attached atthe distal end 52 of the elongated shaft assembly 14 and includes aclamp arm assembly 64 and a blade 66. The jaws of the clamping mechanismof the end effector assembly 26 are formed by clamp arm assembly 64 andthe blade 66. The blade 66 is ultrasonically actuatable and isacoustically coupled to the ultrasonic transducer 16. The trigger 32 onthe handle assembly 12 is ultimately connected to a drive assembly,which together, mechanically cooperate to effect movement of the clamparm assembly 64. Squeezing the trigger 32 in direction 33A moves theclamp arm assembly 64 in direction 62A from an open position, whereinthe clamp arm assembly 64 and the blade 66 are disposed in a spacedrelation relative to one another, to a clamped or closed position,wherein the clamp arm assembly 64 and the blade 66 cooperate to grasptissue therebetween. The clamp arm assembly 64 may comprise a clamp pad69 to engage tissue between the blade 66 and the clamp arm 64. Releasingthe trigger 32 in direction 33B moves the clamp arm assembly 64 indirection 62B from a closed relationship, to an open position, whereinthe clamp arm assembly 64 and the blade 66 are disposed in a spacedrelation relative to one another.

The proximal portion of the handle assembly 12 comprises a proximalopening 68 to receive the distal end of the ultrasonic assembly 16. Theultrasonic assembly 16 is inserted in the proximal opening 68 and ismechanically engaged to the elongated shaft assembly 14.

In one example embodiment, the elongated trigger hook 36 portion of thetrigger 32 provides a longer trigger lever with a shorter span androtation travel. The longer lever of the elongated trigger hook 36allows the user to employ multiple fingers within the aperture 38 tooperate the elongated trigger hook 36 and cause the trigger 32 to pivotin direction 33B to open the jaws of the end effector assembly 26. Forexample, the user may insert three fingers (e.g., the middle, ring, andlittle fingers) in the aperture 38. Multiple fingers allows the surgeonto exert higher input forces on the trigger 32 and the elongated triggerhook 36 to activate the end effector assembly 26. The shorter span androtation travel creates a more comfortable grip when closing orsqueezing the trigger 32 in direction 33A or when opening the trigger 32in the outward opening motion in direction 33B lessening the need toextend the fingers further outward. This substantially lessens handfatigue and strain associated with the outward opening motion of thetrigger 32 in direction 33B. The outward opening motion of the triggermay be spring-assisted by spring element 98 (FIG. 111) to help alleviatefatigue. The opening spring force is sufficient to assist the ease ofopening, but not strong enough to adversely impact the tactile feedbackof tissue tension during spreading dissection.

For example, during a surgical procedure either the index finger may beused to control the rotation of the elongated shaft assembly 14 tolocate the jaws of the end effector assembly 26 in a suitableorientation. The middle and/or the other lower fingers may be used tosqueeze the trigger 32 and grasp tissue within the jaws. Once the jawsare located in the desired position and the jaws are clamped against thetissue, the index finger can be used to activate the toggle switch 30 toadjust the power level of the ultrasonic transducer 16 to treat thetissue. Once the tissue has been treated, the user the may release thetrigger 32 by pushing outwardly in the distal direction against theelongated trigger hook 36 with the middle and/or lower fingers to openthe jaws of the end effector assembly 26. This basic procedure may beperformed without the user having to adjust their grip of the handleassembly 12.

FIGS. 109-110 illustrate the connection of the elongated shaft assembly14 relative to the end effector assembly 26. As previously described, inthe illustrated embodiment, the end effector assembly 26 comprises aclamp arm assembly 64 and a blade 66 to form the jaws of the clampingmechanism. The blade 66 may be an ultrasonically actuatable bladeacoustically coupled to the ultrasonic transducer 16. The trigger 32 ismechanically connected to a drive assembly. Together, the trigger 32 andthe drive assembly mechanically cooperate to move the clamp arm assembly64 to an open position in direction 62A wherein the clamp arm assembly64 and the blade 66 are disposed in spaced relation relative to oneanother, to a clamped or closed position in direction 62B wherein theclamp arm assembly 64 and the blade 66 cooperate to grasp tissuetherebetween. The clamp arm assembly 64 may comprise a clamp pad 69 toengage tissue between the blade 66 and the clamp arm 64. The distal endof the tubular reciprocating tubular actuating member 58 is mechanicallyengaged to the end effector assembly 26. In the illustrated embodiment,the distal end of the tubular reciprocating tubular actuating member 58is mechanically engaged to the clamp arm assembly 64, which is pivotableabout the pivot point 70, to open and close the clamp arm assembly 64 inresponse to the actuation and/or release of the trigger 32. For example,in the illustrated embodiment, the clamp arm assembly 64 is movable froman open position to a closed position in direction 62B about a pivotpoint 70 when the trigger 32 is squeezed in direction 33A. The clamp armassembly 64 is movable from a closed position to an open position indirection 62A about the pivot point 70 when the trigger 32 is releasedor outwardly contacted in direction 33B.

As previously discussed, the clamp arm assembly 64 may compriseelectrodes electrically coupled to the electrosurgical/RF generatormodule 23 to receive therapeutic and/or sub-therapeutic energy, wherethe electrosurgical/RF energy may be applied to the electrodes eithersimultaneously or non-simultaneously with the ultrasonic energy beingapplied to the blade 66. Such energy activations may be applied in anysuitable combinations to achieve a desired tissue effect in cooperationwith an algorithm or other control logic.

FIG. 111 is an exploded view of the ultrasonic surgical instrument 10shown in FIG. 108. In the illustrated embodiment, the exploded viewshows the internal elements of the handle assembly 12, the handleassembly 12, the distal rotation assembly 13, the switch assembly 28,and the elongated shaft assembly 14. In the illustrated embodiment, thefirst and second portions 12 a, 12 b mate to form the handle assembly12. The first and second portions 12 a, 12 b each comprises a pluralityof interfaces 69 dimensioned to mechanically align and engage oneanother to form the handle assembly 12 and enclose the internal workingcomponents of the ultrasonic surgical instrument 10. The rotation knob48 is mechanically engaged to the outer tubular sheath 56 so that it maybe rotated in circular direction 54 up to 360°. The outer tubular sheath56 is located over the reciprocating tubular actuating member 58, whichis mechanically engaged to and retained within the handle assembly 12via a plurality of coupling elements 72. The coupling elements 72 maycomprise an O-ring 72 a, a tube collar cap 72 b, a distal washer 72 c, aproximal washer 72 d, and a thread tube collar 72 e. The reciprocatingtubular actuating member 58 is located within a reciprocating yoke 84,which is retained between the first and second portions 12 a, 12 b ofthe handle assembly 12. The yoke 84 is part of a reciprocating yokeassembly 88. A series of linkages translate the pivotal rotation of theelongated trigger hook 32 to the axial movement of the reciprocatingyoke 84, which controls the opening and closing of the jaws of theclamping mechanism of the end effector assembly 26 at the distal end ofthe ultrasonic surgical instrument 10. In one example embodiment, afour-link design provides mechanical advantage in a relatively shortrotation span, for example.

In one example embodiment, an ultrasonic transmission waveguide 78 isdisposed inside the reciprocating tubular actuating member 58. Thedistal end 52 of the ultrasonic transmission waveguide 78 isacoustically coupled (e.g., directly or indirectly mechanically coupled)to the blade 66 and the proximal end 50 of the ultrasonic transmissionwaveguide 78 is received within the handle assembly 12. The proximal end50 of the ultrasonic transmission waveguide 78 is adapted toacoustically couple to the distal end of the ultrasonic transducer 16 asdiscussed in more detail below. The ultrasonic transmission waveguide 78is isolated from the other elements of the elongated shaft assembly 14by a protective sheath 80 and a plurality of isolation elements 82, suchas silicone rings. The outer tubular sheath 56, the reciprocatingtubular actuating member 58, and the ultrasonic transmission waveguide78 are mechanically engaged by a pin 74. The switch assembly 28comprises the toggle switch 30 and electrical elements 86 a, 86 b toelectrically energize the ultrasonic transducer 16 in accordance withthe activation of the first or second projecting knobs 30 a, 30 b.

In one example embodiment, the outer tubular sheath 56 isolates the useror the patient from the ultrasonic vibrations of the ultrasonictransmission waveguide 78. The outer tubular sheath 56 generallyincludes a hub 76. The outer tubular sheath 56 is threaded onto thedistal end of the handle assembly 12. The ultrasonic transmissionwaveguide 78 extends through the opening of the outer tubular sheath 56and the isolation elements 82 isolate the ultrasonic transmissionwaveguide 24 from the outer tubular sheath 56. The outer tubular sheath56 may be attached to the waveguide 78 with the pin 74. The hole toreceive the pin 74 in the waveguide 78 may occur nominally at adisplacement node. The waveguide 78 may screw or snap into the handpiece handle assembly 12 by a stud. Flat portions on the hub 76 enablethe assembly to be torqued to a required level. In one exampleembodiment, the hub 76 portion of the outer tubular sheath 56 ispreferably constructed from plastic and the tubular elongated portion ofthe outer tubular sheath 56 is fabricated from stainless steel.Alternatively, the ultrasonic transmission waveguide 78 may comprisepolymeric material surrounding it to isolate it from outside contact.

In one example embodiment, the distal end of the ultrasonic transmissionwaveguide 78 may be coupled to the proximal end of the blade 66 by aninternal threaded connection, preferably at or near an antinode. It iscontemplated that the blade 66 may be attached to the ultrasonictransmission waveguide 78 by any suitable means, such as a welded jointor the like. Although the blade 66 may be detachable from the ultrasonictransmission waveguide 78, it is also contemplated that the singleelement end effector (e.g., the blade 66) and the ultrasonictransmission waveguide 78 may be formed as a single unitary piece.

In one example embodiment, the trigger 32 is coupled to a linkagemechanism to translate the rotational motion of the trigger 32 indirections 33A and 33B to the linear motion of the reciprocating tubularactuating member 58 in corresponding directions 60A and 60B. The trigger32 comprises a first set of flanges 98 with openings formed therein toreceive a first yoke pin 92 a. The first yoke pin 92 a is also locatedthrough a set of openings formed at the distal end of the yoke 84. Thetrigger 32 also comprises a second set of flanges 96 to receive a firstend 92 a of a link 92. A trigger pin 90 is received in openings formedin the link 92 and the second set of flanges 96. The trigger pin 90 isreceived in the openings formed in the link 92 and the second set offlanges 96 and is adapted to couple to the first and second portions 12a, 12 b of the handle assembly 12 to form a trigger pivot point for thetrigger 32. A second end 92 b of the link 92 is received in a slot 384formed in a proximal end of the yoke 84 and is retained therein by asecond yoke pin 94 b. As the trigger 32 is pivotally rotated about thepivot point 190 formed by the trigger pin 90, the yoke translateshorizontally along longitudinal axis “T” in a direction indicated byarrows 60A, 60B.

Ultrasonic Blades with Various Grasping Features

FIGS. 1-11 illustrates various embodiments of ultrasonic bladescomprising grasping features. Such grasping features may be included ona gripping surface of an ultrasonic blade to provide additional grippingand prevent tissue milking during grasping and treatment, which in somecases may improve hemostasis. Tissue milking occurs when a tissuesection slides, or milks, out of the jaws of a surgical device duringtreatment. Blade modification features discussed below can preventtissue milking, as well as provide better grasping forces.

A minimum grasping force for an ultrasonic clamp arm in a medicalforceps having a movable jaw member is about 2.25 lb-f when clamped on adry chamois while the device is inactive. During activation, however,the tissue may milk out of the jaws either proximally or distally. Theblade 100 comprising the tooth-like grasping features 102 for anultrasonic shears device can help prevent tissue milking as well asprovide better grasping forces.

Grasping features may take the form of several shapes as described inconnection with FIGS. 1-11, for example. The grasping features could belocated only on a portion of the blade, such as, for example, the distaltip, the center of the blade, the proximal section, or any portion ofthe blade. In another embodiment, the grasping features may be locatedalong the entire length or a portion of the blade. In some embodiments,the features illustrated and described with respect to FIGS. 1-11 couldbe located longitudinally on a portion of the blade, such as, forexample, configured along a center line of the blade, the left side ofthe blade, the right side of the blade, or both the right and left sideof the blade. In another embodiment, the grasping features may beconfigured along the entire width of the blade. Grasping features mayinclude, for example, teeth machined into the blade, teeth protrudingfrom the surface of the blade, protruding blocks, protruding bumps orspikes, holes formed in the blade, or protruding elongated bumps. Theseand other blade grasping features are described hereinbelow inconnection with FIGS. 1-11.

FIG. 1 illustrates one embodiment of an ultrasonic blade 100 withtooth-like grasping features 102 formed on a grasping surface 104 of theblade 100. In the embodiment illustrated in FIG. 1 the tooth-likegrasping features 102 are formed along lateral portions 106, 108 of thegrasping surface 104 of the blade 100, e.g., the left side of the blade100 and the right side of the blade 100. In one embodiment, thetooth-like grasping features 102 may be formed along the entire activelength or a portion of the blade 100. Elements of the tooth-likegrasping features 102 may be uniformly or variable spaced. In otherembodiments, the tooth-like grasping features 102 could be located onlyon a portion of the blade 100, such as, for example, the distal tip 110,the center 112 of the blade 100, the proximal section 114, or anyportion of the blade 100. In another embodiment, the tooth-like graspingfeatures 102 may be located along the entire length or a portion of theblade 100. In some embodiments, the tooth-like grasping features 102could be located longitudinally on a portion of the blade 100, such as,for example, configured along a center line 116 of the blade 100, theleft side 108 of the blade 100, the right side 106 of the blade 100, orboth the right and left side of the blade 100. In another embodiment,the tooth-like grasping features 102 may be configured along the entirewidth of the blade 100. The tooth-like grasping features 102 may beconfigured to trap tissue and prevent disengagement during activation toprevent tissue milking, as well as provide better grasping forces.Accordingly, the tooth-like grasping features 102 formed on the blade100 improve tissue grasping. The embodiments, however, are not limitedin this context.

FIG. 2 illustrates one embodiment of an ultrasonic blade 200 withtooth-like grasping features 202 formed on a grasping portion 204 of theblade 200 where the teeth are machined into the grasping portion 204 ofthe blade 200. In the embodiment illustrated in FIG. 2, the blade 200 ispart of a medical forceps 206 having a movable jaw member 208, which iscommonly referred to as a clamp arm. The movable jaw member 208comprises a clamp pad 210 to engage tissue between the blade 200 and themovable jaw member 208, e.g., clamp arm. In one embodiment, thetooth-like grasping features 202 may be formed along the entire activelength or a portion of the blade 200. Elements of the tooth-likegrasping features 202 may be uniformly or variable spaced. Although notshown, the tooth-like grasping features 202 may be formed across thegrasping surface 204 of the blade 200, may be formed as multiple rowsalong the lateral portions of the blade 200 as shown in FIG. 1, or maybe formed as a single row along the longitudinal portion of the graspingsurface 204 of the blade 200. The tooth-like grasping features 202 maybe configured to trap tissue and prevent disengagement during activationto prevent tissue milking, as well as provide better grasping forces.Accordingly, the tooth-like grasping features 202 formed on the blade200 improve tissue grasping. The embodiments, however, are not limitedin this context.

FIG. 3 illustrates one embodiment of an ultrasonic blade 300 withtooth-like grasping features 302 formed on a grasping portion 304 of theblade 300, where the teeth 302 protrude from the grasping portion 304 ofthe blade 300. In the embodiment illustrated in FIG. 3, the blade 300 ispart of a medical forceps 306 having a movable jaw member 308, which iscommonly referred to as a clamp arm. The movable jaw member 308comprises a clamp pad 310 to engage tissue between the blade 300 and themovable jaw member 308, e.g., clamp arm. In one embodiment, thetooth-like grasping features 302 may be formed along the entire activelength or a portion of the blade 300. Elements of the tooth-likegrasping features 302 may be uniformly or variable spaced. Although notshown, the tooth-like grasping features 302 may be formed across thegrasping surface 304 of the blade 300, may be formed as multiple rowsalong the lateral portions of the blade 300 as shown in FIG. 1, or maybe formed as a single row along the longitudinal portion of the graspingsurface 304 of the blade 300. The tooth-like grasping features 302 maybe configured to trap tissue and prevent disengagement during activationto prevent tissue milking, as well as provide better grasping forces.Accordingly, the tooth-like grasping features 302 formed on the blade300 improve tissue grasping. The embodiments, however, are not limitedin this context.

FIG. 4 illustrates one embodiment of an ultrasonic blade 400 withprotruding block-like grasping features 402 formed on a grasping 404portion of the blade 400. FIG. 5 is a side view of the ultrasonic bladeshown in FIG. 4. In the embodiment illustrated in FIGS. 4 and 5 theblock-like grasping features 402 are formed along lateral portions 406,408 of the grasping surface 404 of the blade 400. In one embodiment, theblock-like grasping features 402 may be formed along the entire activelength or a portion of the blade 400. Elements of the block-likegrasping features 402 may be uniformly or variable spaced. In otherembodiments, the block-like grasping features 402 could be located onlyon a portion of the blade 400, such as, for example, the distal tip 410,the center 412 of the blade 400, the proximal section 414, or anyportion of the blade 400. In another embodiment, the block-like graspingfeatures 402 may be located along the entire length or a portion of theblade 400. In some embodiments, the block-like grasping features 402could be located longitudinally on a portion of the blade 400, such as,for example, configured along a center line 416 of the blade 400, theleft side 408 of the blade 400, the right side 406 of the blade 400, orboth the right and left side of the blade 400. In another embodiment,the block-like grasping features 402 may be configured along the entirewidth of the blade 400. The block-like grasping features 402 may beconfigured to trap tissue and prevent disengagement during activation toprevent tissue milking, as well as provide better grasping forces.Accordingly, the block-like grasping features 402 formed on the blade400 improve tissue grasping. The embodiments, however, are not limitedin this context.

FIG. 6 illustrates one embodiment of an ultrasonic blade 500 withprotruding grasping features 502 formed on a grasping portion 504 of theblade 500. FIG. 7A is a side view of the ultrasonic blade 500 shown inFIG. 6 and FIG. 7B shows the protruding grasping features 502 in theform of bump-like protrusions 510 whereas FIG. 7C shows the protrudinggrasping features 502 in the form of spike-like protrusions 512. In theembodiment illustrated in FIGS. 6 and 7A the protruding graspingfeatures 502 are formed along lateral portions 506, 508 of the graspingsurface 504 of the blade 500. In one embodiment, the grasping features502 may be formed along the entire active length or a portion of theblade 500. Elements of the grasping features 502 may be uniformly orvariable spaced. In other embodiments, the grasping features 502 couldbe located only on a portion of the blade 500, such as, for example, thedistal tip 520, the center 522 of the blade 500, the proximal section524, or any portion of the blade 500. In another embodiment, thegrasping features 502 may be located along the entire length or aportion of the blade 500. In some embodiments, the grasping features 502could be located longitudinally on a portion of the blade 500, such as,for example, configured along a center line 526 of the blade 500, theleft side 508 of the blade 500, the right side 506 of the blade 500, orboth the right and left side of the blade 500. In another embodiment,the grasping features 502 may be configured along the entire width ofthe blade 500. The grasping features 502 may be configured to traptissue and prevent disengagement during activation to prevent tissuemilking, as well as provide better grasping forces. Accordingly, thegrasping features 502 formed on the blade 500 improve tissue grasping.The embodiments, however, are not limited in this context.

FIG. 8 illustrates one embodiment of an ultrasonic blade 600 withcavity-like grasping features 602 formed on a grasping portion 604 ofthe blade 600. FIG. 9A is a side view of an ultrasonic blade 600 havingcylindrical cavity-like grasping features 611 partially formed into thegrasping portion of the blade 610. FIG. 9B is a side view of anultrasonic blade 600 having cylindrical cavity-like grasping features613 formed through a grasping portion of the blade 612. FIG. 9C is aside view of an ultrasonic blade 600 having conical cavity-like graspingfeatures 615 partially formed into the grasping portion of the blade614. In the embodiment illustrated in FIGS. 8 and 9A-C, the cavity-likegrasping features 602 are distributed along portions of the graspingsurface 604 of the blade 600. In one embodiment, the grasping features602 may be formed along the entire active length or a portion of theblade 600. Elements of the grasping features 602 may be uniformly orvariable spaced. In other embodiments, the grasping features 602 couldbe located only on a portion of the blade 600, such as, for example, thedistal tip 620, the center 622 of the blade 600, the proximal section624, or any portion of the blade 600. In another embodiment, thegrasping features 602 may be located along the entire length or aportion of the blade 600. In some embodiments, the grasping features 602could be located longitudinally on a portion of the blade 600, such as,for example, configured along a center line 626 of the blade 600, theleft side 608 of the blade 600, the right side 606 of the blade 600, orboth the right and left side of the blade 600. In another embodiment,the grasping features 602 may be configured along the entire width ofthe blade 600. The grasping features 602 may be configured to traptissue and prevent disengagement during activation to prevent tissuemilking, as well as provide better grasping forces. Accordingly, thegrasping features 602 formed on the blade 600 improve tissue grasping.The embodiments, however, are not limited in this context.

FIG. 10 illustrates one embodiment of an ultrasonic blade 700 withtransverse bump-like grasping features 702 formed on a grasping portion704 of the blade 700. FIG. 11 is a side view of the ultrasonic blade 700shown in FIG. 10. In the embodiment illustrated in FIGS. 10 and 11, thetransverse bump-like grasping features 702 are distributed transversallyalong across of the grasping surface 704 of the blade 700. In oneembodiment, the transverse bump-like grasping features 702 may be formedalong the entire active length or a portion of the blade 700. Elementsof the transverse bump-like grasping features 702 may be uniformly orvariable spaced. In other embodiments, the transverse bump-like graspingfeatures 702 could be located only on a portion of the blade 700, suchas, for example, the distal tip 720, the center 722 of the blade 700,the proximal section 724, or any portion of the blade 700. In anotherembodiment, the transverse bump-like grasping features 702 may belocated along the entire length or a portion of the blade 700. In someembodiments, the transverse bump-like grasping features 702 could belocated longitudinally on a portion of the blade 700, such as, forexample, configured along a center line 726 of the blade 700, the leftside 708 of the blade 700, the right side 706 of the blade 700, or boththe right and left side of the blade 700. In another embodiment, thetransverse bump-like grasping features 702 may be configured along theentire width of the blade 700. The transverse bump-like graspingfeatures 702 may be configured to trap tissue and prevent disengagementduring activation to prevent tissue milking, as well as provide bettergrasping forces. Accordingly, the transverse bump-like grasping features702 formed on the blade 700 improve tissue grasping. The embodiments,however, are not limited in this context.

FIG. 12 is a side view of one embodiment of an end effector assemblycomprising medical forceps 800 having a movable jaw member 802 and anultrasonic blade 804 having protrusions 806 in the form of tooth-likegrasping features formed in the grasping surface 808 of the blade 804.FIG. 13 is a top view of one embodiment of the medical forceps 800 shownin FIG. 12 with the movable jaw member 802 drawn in phantom line to showthe ultrasonic blade 804 positioned below the movable jaw member 802.

In one embodiment, the protrusions 806 (e.g., teeth) may be defined byseveral dimensions. A first dimension “a” represents the height of aprotrusion 806 (e.g., tooth). In one embodiment, the dimension “a” maybe about 0.12 mm to 0.18 mm. A second dimension “b” represents the widthof a protrusion 806 (e.g., tooth). In one embodiment, the dimension “b”may be about 0.2 mm. A third dimension “c” represents the spacingbetween each protrusion 806. In one embodiment, the dimension “c” isabout 0.5 mm. The protrusions 806 may cover, in one embodiment, adistance represented by dimension “d” which can be as little as 2 mm ofthe blade 804 to provide additional grasping strength. The 2 mm ofprotrusions 806 may comprise any percentage of the blade 804, such as,for example, 13% of a 15 mm blade. In one embodiment, the height of theprotrusion 806 near the distal end 810 of the blade 804 may beapproximately 2.3 mm. In one embodiment, the protrusions 806 maycomprise about 5% of the total height of the blade 804. In variousembodiments, the protrusions 806 may include a pitch of 0.3 mm-1.0 mm, adepth of approximately 0.08 mm-0.8 mm, and an angle of approximately5-90 degrees. In various embodiments, the protrusions 806 may be in theform of blocks, bumps, spikes, or speed bumps, as previously described.These alternate embodiments of the protrusions 806 would be formedhaving similar dimensions as the protrusions 806 described in connectionwith FIGS. 12 and 13 to have a similar affect on tissue, e.g.,statistically better tissue grasping forces and preventing tissuemilking.

In one embodiment, the protrusions 806 may mate with alternatingfeatures formed on the clamp arm 802 or tissue pad 812 portion of themedical forceps 800. In another embodiment, this mating is neithernecessary nor required. In one non-mating embodiment, graspingefficiency may be increased by 64% using three features in the form ofteeth. The presence of the features does not affect the tissuetransection ability of the blade 804. In one embodiment, the blade 804may comprise protrusions 806 along the entire active length of the blade804. The protrusions 806 may be configured to trap tissue and preventdisengagement during activation. Various embodiments of protrusions 806may include blade teeth, horizontal trenches, or cavities, as previouslydescribed.

FIGS. 14-18 illustrate various embodiments of ultrasonic bladescomprising blade features is to address tissue milking. As previouslydiscussed, tissue milking is defined as the event in which tissue beginsto slip out of the jaws of an ultrasonic medical forceps having amovable jaw member and an ultrasonic blade upon device activation. Thisevent increases the difficulty of manipulating tissue in lowaccessibility conditions. To address this and other issues, the presentdisclosure provides three embodiments to improve the grasping abilityduring ultrasonic activation. At least one embodiment of each of thedisclosed ultrasonic blades employs repeated features across the activelength of the blade. These features are designed to trap tissue andprevent disengagement during activation. Based on the testing, thefollowing embodiments have shown between a 30% and 40% improvement ingrasping force during activation over conventional ultrasonic blades.The three embodiments provide ultrasonic blade teeth geometries in theform of blade teeth, horizontal trenches, and holes (e.g., cavities) asdescribed hereinbelow in connection with FIGS. 14-18 to preventdisengagement of tissue from the blade and clamp arm upon ultrasonicactivation of the device and to improve tissue grasping ability prior toand during ultrasonic activation. In various embodiments, the ultrasonicblades comprise tissue trapping features to improve grasping ability andprevent tissue disengagement during ultrasonic activation of the blade.

FIG. 14 is a side view illustrating one embodiment of an ultrasonicblade 900 comprising tooth-like grasping features 902 having triangulargrooves formed on a grasping surface 904 of the blade 900. FIG. 15 is atop view of the ultrasonic blade 900 shown in FIG. 14. The blade 900comprises a proximal end 910 and a distal end 909. The blade 900comprises tissue trapping features 902 in the form of triangular groovesrepeated along a portion of or the entire longitudinal length of theblade 900. A distal side 906 toward the distal end 909 of the blade 900of each feature 902 may be a surface perpendicular to the longitudinalaxis of the blade 900 followed by an angled surface 908 that tapers offin a proximal direction 910. In one embodiment, the features 902 may becharacterized by dimensions a, b, c, and d. In one embodiment, dimension“a” represents the heights of the feature 902, which may beapproximately 0.010″, “b” represents the width of the feature 902, whichmay be approximately 0.020″, “c” represents the distance between thefeatures 902, which may be approximately 0.055″, and “d” represents thedistance from the most distal feature 902 to the distal 909 tip of theblade 900, which may be approximately 0.015″. In one embodiment, thefeatures 902 may be evenly spaced along the longitudinal length of theblade 900. In another embodiment, the triangular grooves graspingfeatures 902 may be unevenly spaced along the longitudinal length of theblade 900. In the illustrated embodiment, the blade 900 comprises 12evenly spaced triangular grooves grasping features 902 along thelongitudinal length of the blade 900.

FIG. 16 is a side view illustrating one embodiment of an ultrasonicblade 950 with tooth-like grasping features 952 including horizontaltrenches having repeated semicircular grooves formed on a graspingsurface 954 of the blade 950. FIG. 17 is a top view of the ultrasonicblade 950 shown in FIG. 16. The blade 950 comprises a proximal end 960and a distal end 959. The blade 950 comprises tissue trapping features952 in the form of horizontal trenches having semicircular groovesrepeated along the longitudinal length of the blade 950. In oneembodiment, the features 952 may be characterized by dimensions e, f, g,and h. In one embodiment, dimension “e” represents the diameter of thegrooves, which may be approximately 0.020″, “f′ represents the distancebetween each of the features 952, which may be approximately 0.057”, “g”represents the distance from the most distal feature 952 to the distal909 tip of the blade 950, which may be approximately 0.015″, and “h”represents the depth of the grooves which may be approximately 0.005″.In one embodiment, the features 952 may be evenly spaced along thelongitudinal length of the blade 950. In another embodiment, thesemicircular groove grasping features 952 may be unevenly spaced alongthe longitudinal length of the blade 950. In the illustrated embodiment,the blade 950 comprises 12 evenly spaced semicircular groove graspingfeatures 952 along the longitudinal length of the blade 950.

FIG. 18 is a top view illustrating one embodiment of an ultrasonic blade970 comprising grasping features 972 including cavities or holes formedon a grasping surface 974 of the blade 970. The blade 970 comprises aproximal end 980 and a distal end 979. The blade 970 comprises tissuetrapping features 972 in the form of circular elements repeated alongthe longitudinal length of the blade 970. In one embodiment, thefeatures 972 may be characterized by dimensions i, j, and k. In oneembodiment, dimension “k” represents the diameter of a circular element,which may be approximately 0.020″, “i” represents the distance betweeneach of the circular features 972, which may be approximately 0.057″,and “j” represents the distance from the most distal feature 972′ to thedistal 979 tip of the blade 970, which may be approximately 0.015″. Inone embodiment, the circular features 972 may be evenly spaced along thelongitudinal length of the blade 970. In another embodiment, thecircular features 972 may be unevenly spaced along the longitudinallength of the blade 970. In the illustrated embodiment, the blade 970comprises 12 evenly spaced circular grasping features 972 along thelongitudinal length of the blade 970.

Ingress Prevention

The present disclosure describes various embodiments of devices toprevent surgical matter, such as fluid or tissue, for example, fromentering the space between an ultrasonic blade and an inner tube distalof the blade's distal seal. Two main categories of embodiments aredescribed. First, a pressure or energy source attached to the blade-tubesubassembly prevents fluid or tissue ingress into the space between theblade and the inner tube. Second, a flexible membrane(s) attached toeither the blade or the inner tube prevents fluid or tissue ingress.

In one embodiment, surgical matter in the form of fluid or tissue, forexample, could be prevented from entering the distal inner tube area bythe application of a constant pressure of a fluid medium (e.g., air, CO₂or saline solution) in the distal direction. FIG. 32 illustrates oneembodiment of a positive pressure fluid flow system 2300 comprising apump and/or pump outlet 2306 located distal of the distal seal. In theillustrated embodiment, the external pump and/or pump outlet 2306 isfluidically coupled to the device distal of the distal node of anultrasonic blade 2304. Air or other fluid medium 2308 is pumped into thespace 2310 between the blade 2304 and the inner tube 2302, forcingparticulates and/or bodily fluids out of that space 2310. As illustratedin FIG. 32, the pump and/or pump outlet 2306 is fluidically coupled tothe space 2310 between the tube 2302 and the blade 2304 at a pointdistal from a distal blade seal 2312, e.g., an O-ring or overmoldedseal. Thus, the positive pressure fluid flow 2308 is directed to thedistal end of the device to prevent accumulation of surgical matter inthe space 2310.

FIG. 49 illustrates one embodiment of a positive fluid pressure system3500 in which air 3508 is pumped down the length of the inner tube 3502through space 3506. The air 3508 prevents surgical matter from enteringthe space 3510 between the ultrasonic blade 3504 and the inner tube3502. FIG. 49 shows a similar concept to that shown in FIG. 32, but thedistal node does not have a seal to the inner tube 3502. Rather, air3508 is pumped down the full length of the inner tube 3502 to preventfluid and/or tissue ingress.

FIG. 26 illustrates one embodiment of a hybrid system comprising acontoured seal 1700 comprising a flexible membrane 1701 that acts as apump to force surgical matter 1714 out of a distal tube 1706 area. Thepressurized flexible membrane 1701 blocks tissue ingress by contact. Theflexible membrane 1701 is attached to the inner tube 1706 and sealed tothe ultrasonic blade 1704. Thus, the relative movement between the blade1704 and the distal tube 1706 causes the flexible membrane 1701 to actin a pump-like manner to force fluids, tissue, or other surgical matterto flow along the contour of the flexible membrane 1701 and out of theinner tube 1706 area. The contoured seal 1700 seals a space 1702 betweena portion of an ultrasonic blade 1704 and a tube 1706. The contouredseal 1700 has two points of contact 1708, 1710 with the ultrasonic blade1704 to minimize friction and interference and to provide a double seal.A cavity 1712 is defined by the contoured seal 1700 for collectingsurgical matter 1714. In an alternative embodiment, a separate duct 1718may be provided to apply a positive pressure to the flexible membrane ofthe contoured seal 1700 to expel the surgical matter 1714 from thecavity 1712.

In various other embodiments, a boot barrier (or seal, for example) maybe added to an end effector portion of an ultrasonic instrument toprevent the buildup of surgical matter on the end effector. The bootbarrier seals the ultrasonic blade to the distal ends of one or moretube(s) near to the proximal end of the tissue effecting portion of theultrasonic blade. The boot barrier may be made from any suitablematerials including compliant, thermally robust material that has arelatively low coefficient of friction in order to minimize the sealload on the blade. Materials suitable for the boot barrier may include,for example, silicone rubber, parylene coated silicon rubber,Tetrafluoroethylene-hexafluoropropylene (FEP), which has similarproperties to those of Polytetrafluoroethylene (PTFE) otherwise known inthe trade as Teflon, shrink tubing, or any similar material. In anotherembodiment, the blade may be coated to reduce power draw of theinstrument due to inclusion of the boot barrier.

The boot barrier seals to the blade and may provide slight interferenceto the blade. Where the boot barrier seals to the blade, the bootbarrier does not provide vertical reaction for clamping/bending of theblade in order to keep the load on the blade (from the boot) minimized.The boot barrier may seal to the outer diameter of the tube(s), theinner diameter of the tube(s) or both. One or more retention featuresmay be provided on the blade and/or the tube(s) for retaining the bootto the blade and/or the tube(s). In one embodiment, the retentionfeatures may also be located on the boot barrier itself.

Generally, the boot barrier prevents build up and accumulation ofsurgical matter such as, for example, tissue, blood, melted fat, andother related materials encountered during surgery, between the distalportion of the tube(s) and the nearby portion of the blade of theultrasonic surgery device. This build up and accumulation may result inlarge and inconsistent mechanical loads on the system resulting inprocedure interruptions due to high impedance either causing resonanceissues or causing the system to bog down and potentially stop duringactivation. The tube(s) are needed to protect tissue and users from theultrasonically active blade and, in the case of shears-type device, tosupport and/or drive a clamp arm. Ideally, the ultrasonic blade is asactive (ultrasonically) as possible in the proximal portion of itstissue effecting length. Solutions that maximize this ultrasonicactivity also elongate the portion of the blade between its most distalnode and the proximal end its tissue effecting length. The result is arelatively large annular volume that accumulates tissue, blood, fat,etc. with the aforementioned issues.

FIG. 19 illustrates one embodiment of an end effector assembly 1000comprising a medical forceps having a movable jaw member 1002 and anultrasonic blade 1004. The jaw member 1002 is movable in direction 1016.A flexible boot barrier 1006 is positioned over a proximal portion 1008of the blade 1004 and a distal portion of a tube 1010 to seal the blade1004 to an outer diameter 1012 of the tube 1010. A retention feature1014 may be provided on the outer diameter 1012 of the tube 1010 to keepthe boot barrier 1006 in place. As previously discussed, the bootbarrier 1006 may be made from silicone rubber or other similarmaterials. In one embodiment, the boot barrier 1006 may be coated with alubricious material such as parylene, for example, to reduce friction.In an alternative embodiment, the blade 1104 may be coated with similarlubricious materials to reduce friction. Reducing friction between theblade 1004 and the boot barrier 1006 reduces power draw due to theinclusion of the boot barrier 1006.

FIG. 20 illustrates one embodiment of an end effector assembly 1100comprising a medical forceps having a movable jaw member 1102 and anultrasonic blade 1104. A flexible seal 1106 positioned over a proximalportion 1108 of the blade 1104 and within a distal portion 1110 of aninner tube 1112 to seal the blade 1104 to an inner diameter 1114 of theinner tube 1112. The inner tube 1112 is slidably movable within an outertube 1116.

FIG. 21 illustrates one embodiment of a slotted inner tube 1200 toconceal a lengthwise portion of an ultrasonic blade 1202. Slots 1204provide fluid/tissue egress to discharge surgical matter that mayaccumulate in a space 1206 between the blade 1202 and the inner tube1200. Fluid/tissue egress through the slots 1204 at the distal end of anultrasonic device prevents the accumulation of surgical matter. Inultrasonic laparoscopic shears, for example, an overmolded siliconedistal seal 1208 is provided on or near the distal node of the blade1202. A boot barrier may be overmolded, positioned just distal to theclamp arm edge, which could prevent tissue pinching, and anchored to theinner tube 1200, or positioned within the inner tube 1200 andnon-visible to the user as shown in FIG. 22, for example. In thesedevices, there is approximately 13 mm length of the blade 1202 that isconcealed by the outer tube (not shown) and the inner tube 1200 beforethe distal seal 1208 is present. Surgical matter, such as fluid, blood,fat, or other tissue, can become lodged in that space between the outerdiameter of the blade 1202 and the inner diameter of the inner tube1200. In other instruments comprising similar shears, the length ofexposed blade may increase thus increasing the chance of tissue lodgingtherein. This could result in increased transection times as thefluid/tissue becomes a heat sink or in relaxed pressure on the blade ifthe fluid/tissue hardens from applied blade heat. Additionally, if an RFmodality is to be added to ultrasonic lap shears technology, tissue andfluid could cause a short circuit if the RF energy is allowed to flowfrom the blade through tissue that is inside the inner tube, rather thanthe desired energy path along the active (exposed) length of the blade.Thus a boot or distal tissue ingress prevention method or mechanism isprovided as described herein below in connection with FIGS. 21-23 wheresurgical matter such as fluid or tissue is expelled from between theinner tube 1200 and the blade 1202 by slots 1204, windows, apertures, orperforations formed in the inner tube 1200.

FIG. 22 illustrates one embodiment of a perforated inner tube 1300 toconceal a lengthwise portion of an ultrasonic blade 1302. The inner tube1300 is perforated with holes 1304 to allow surgical matter such asfluids/tissue to escape. The perforations 1304 provide fluid/tissueegress to discharge surgical matter that may accumulate in a space 1306between the blade 1302 and the inner tube 1300. In the illustratedembodiment, the inner tube 1300 comprises a 180° half circle and isperforated with holes 1304 to allow fluids/tissue to escape. The tube1300 is located between the active blade 1302 and the distal mostovermold 1310 portion, which is located a distance 1308 from the distaltip of the blade 1302.

FIG. 23 illustrates one embodiment of a fluid-directing ribbed andperforated inner tube 1400 to conceal a lengthwise portion 1401 of anultrasonic blade 1402. Fluid-directing ribs 1404 perforations 1406provide fluid egress to discharge surgical matter that may accumulate ina space 1410 between the blade 1402 and the inner tube 1400. The distalmost overmold is located at a distance 1408 from the distal tip of theblade 1402. In the illustrated embodiment, the ribs 1404 radiate inwardand comprise holes 1406 located between each rib. The ribs 1404 have aclearance with respect to the blade 1402. The spacing of the ribs 1404is such that only fluids can pass, not solids of appreciable size. Thechanneling configuration raises fluid velocity and raises likelihood ofclearing out of holes 1406.

FIG. 24 is one embodiment of a fluid-directing ribbed and perforatedinner tube 1500 comprising converging ducts 1502. In one embodiment, theconverging ducts 1502 are fluidically coupled to apertures 1504 toprovide fluid egress to discharge surgical matter.

FIG. 25 illustrates one embodiment of a contoured seal 1600 to seal aspace 1602 between a portion of an ultrasonic blade 1604 distal to thedistal seal and a tube 1606. The contoured flexible seal 1600 has twopoints of contact 1608, 1610 with the ultrasonic blade 1604 to minimizefriction and interference and to provide a double seal. A cavity 1612 isdefined by the contoured flexible seal 1600 for collecting surgicalmatter 1614.

FIG. 27 illustrates one embodiment of a seal 1800 to seal a space 1802between a portion of an ultrasonic blade 1804 distal to the distal sealand a tube 1806. The flexible seal 1800 has multiple points of contact1808 to provide low interference point of contact between the seal 1800and the blade 1804. The multiple points of contact 1808 reduce fluidwicking up the shaft of the blade 1804. A nose portion 1810 of the seal1800 and the multiple points of contact 1808 block surgical matter fromentering into the space 1802 between the blade 1804 and the tube 1806.

FIG. 28 illustrates etched areas 1902 formed on an outer surface 1904 ofan ultrasonic blade 1900 to prevent fluid/tissue ingress along the bladedue to blade vibration.

FIG. 29 illustrates one embodiment of an end effector assembly 2000comprising a medical forceps having a movable jaw 2002 member and aslidable ultrasonic blade 2004 partially retracted within a seal 2006.The movable jaw member 2002 comprises a clamp pad 2014 having a livinghinge formed by necked down regions 2012 at the interface of the clamppad 2014 and the seal 2006. The blade 2004 is slidable in direction 2010and is received within the seal 2006. The seal 2006 is coupled to aninner tube 2008 to seal the blade 2004 to the tube 2008 and preventfluid/tissue migration proximally.

FIG. 30 illustrates one embodiment of an inner tube 2100 having machinedwindows 2102 formed therein. The windows 2102 allow drainage between theinner 2100 and an outer tube. This embodiment may be an alternative tothe embodiment show in FIG. 21, for example.

FIG. 31 illustrates one embodiment of an end effector assembly 2200comprising a medical forceps having a movable jaw member 2202 and anultrasonic blade 2204. The movable jaw member 2202 comprises an extendedclamp arm pad 2206 that follows the contour of the movable jaw member2202 (e.g., clamp arm) into the space around the blade 2204 to cover theopening of the inner tube with a tissue stop element 2208. The tissuestop element 2208 deflects surgical matter and prevents it from enteringthe space between the blade 2204 and the inner tube 2212. The tissuestop element 2208 is contoured to the movable jaw member 2202 to coveran opening 2210 of the inner tube 2212. In one embodiment, the clamp armpad 2206 is machined with the tissue stop 2208 element to provideminimal interference between the blade 2204 and the tube 2212. The pad2206 and/or the tissue stop element 2208 may be made of a lubriciousmaterial such as Teflon to minimize the load on the blade 2204.

FIG. 38 illustrates one embodiment of an end effector assembly 2900comprising a medical forceps having a movable jaw member 2902 and anultrasonic blade 2904. The movable jaw member 2902 comprises a clamp armpad 2908 having a deflector pad 2906 to deflect surgical matter.

FIG. 39 is a front view of the clamp arm pad 2908 and deflector pad 2906shown in FIG. 38. An aperture 2910 is provided in the deflector pad 2906to receive the ultrasonic blade 2904 therethrough.

FIG. 33 illustrates a portion of an end effector assembly 2400comprising an ultrasonic blade 2404 including one embodiment of a bootbarrier 2402 to seal the ultrasonic blade 2404 to a tube 2406 distal tothe distal node 2410 of the blade. In one embodiment, the boot barrier2402 seals the blade 2404 to an inner tube 2406 which is disposed withinan outer tube 2408. In the embodiment illustrate din FIG. 33, the bootbarrier 2402 may be formed of FEP to cover high stress regions of theblade 2404. In the illustrated embodiment, the outer tube 2408 ends at ablade distal node 2410.

FIG. 34 illustrates one embodiment of an end effector assembly 2500comprising a medical forceps having a movable jaw member 2502 and anultrasonic blade 2504 including a flexible seal 2506 positioned distalto an edge 2508 of the movable jaw member 2502 and anchored to an outertube 2510 to prevent tissue pinching. An inner tube 2512 is positionedwithin the outer tube 2510. The blade 2504 is positioned within theinner tube 2512.

FIG. 35 illustrates one embodiment of an end effector assembly 2600comprising a seal 2606 positioned within an inner tube 2602 and anultrasonic blade 2604 positioned within the inner tube 2602 such that itis non-visible to the user. The seal 2602 may either be a low frictionmaterial to minimize load on the blade 2604 or a small clearance 2608may be provided between the seal 2606 and the blade 2604 to preventcontact with the blade. The seal 2606 seals the space 2610 definedbetween the blade 2604 distal to the distal seal and an inner diameterof the inner tube 2602 to prevent the accumulation of surgical mattertherein.

FIG. 36 illustrates one embodiment of a seal mechanism 2700 for anultrasonic blade 2702 having a tapered inner tube 2704 portion distal tothe blade distal seal 2716 where the inner tube 2704 necks down 2706 toa smaller diameter at a distal end defining a reduced entry space 2708for surgical matter. A conventional outer tube 2710 is provided over thetapered inner tube 2704. The diameter of the inner tube portion 2712proximal to the necked down region 2706 is greater than the diameter ofthe inner tube portion 2714 distal to the necked down region 2706. Inone embodiment, the necked down region 2706 coincides with the locationjust distal to the distal-most overmold 2716. In one embodiment, theinner tube 2704 may be necked down for a portion distal to thedistal-most seal, to provide less open space for fluids and solids toenter.

FIG. 37 illustrates one embodiment of an overmolded flexible seal 2800located over an inner tube 2802 that an ultrasonic blade 2804 puncturesthrough during assembly. As shown, as the blade 2804 is moved distallyin direction 2806 during device assembly, the blade 2804 breaks throughthe overmolded flexible seal 2800 to seal the space 2808 between theblade 2804 and the inner tube 2802. A clamp arm pivot hole 2814 in theouter tube distal clevis 2816 enables a movable jaw member to open andclose. An outer tube distal clevis 2816 is located on a distal end of anouter tube. In one embodiment, the clevis 2816 can be welded on thedistal end of the outer tube.

FIG. 40 illustrates one embodiment of a seal system 3000 for anultrasonic blade 3002. A flexible seal 3004 seals the ultrasonic blade3002 distal to a distal seal portion 3008. In one embodiment, theflexible seal 3004 seals the blade 3002 to the inner diameter of theinner tube 3006.

FIG. 41 illustrates one embodiment of a contoured inner tube 3100 orcomponent that attaches to an inner tube 3100 to provide a circuitouspath 3104 for fluid. An area of the inner tube 3100 comprises a locallyswaged pair of grooves 3106, 3108 that may be employed to locate anO-ring that would touch the blade or provide a circuitous path toprevent ingress of fluids during use.

FIG. 42 illustrates one embodiment of a molded component 3110 withcompliant arms that serves to block the distal opening of a tubeassembly and is attached via arms going around a pin in the blade at anode location.

FIG. 43 illustrates one embodiment of an overmolded silicone bumper 3112that adheres to the inside of an inner tube. The bumper 3112 preventsfluid ingress and does not nominally touch the blade so there is noincrease in blade loading during use.

FIGS. 44-47 illustrate one embodiment of how a pair of mandrels 3120A,3120B can be inserted into an inner 3122 tube from both ends. Themandrels 3120A, 3120B combine to form an overmold channel into which thesilicone (or equivalent) bumper 3124 material would be injected. Themandrels would then be removed leaving just the bumper 3124.

FIG. 48 illustrates an end view of a seal system 3200 comprising anovermolded bumper 3124 affixed to an inner tube 3202 that does not sealto an ultrasonic blade 3204. In the illustrated embodiment, the sealsystem 3200 is an end view of the tube assembly shown in FIG. 47 withthe molded bumper 3124 in place.

FIG. 50 illustrates one embodiment of an inner tube 3600 comprisinghaving a silicone seal 3602 attached thereto at minimal interferencewith an ultrasonic blade.

FIG. 51 illustrates one embodiment of seal system 3700 for sealing anultrasonic blade 3704 to a tube 3706. In the illustrated embodiment, thesealing system 3700 comprises a funnel 3702 to prevent ingress ofsurgical matter in the space 3708 between the blade 3704 distal to thedistal node and the inner tube 3706. The funnel 3702 deflects surgicalmatter distally.

FIG. 52 illustrates one embodiment of a flexible seal 3802 located overan inner tube 3800 that an ultrasonic blade punctures through anddilates at location 3804 during assembly.

FIG. 53 illustrates one embodiment of an overmolded flexible seal 3900attached to an ultrasonic blade 3902 distal of the distal node.

FIG. 54 illustrates one embodiment of an overmolded flexible seal 4000attached to an ultrasonic blade 4002 distal of the distal node. In oneembodiment, the overmolded flexible seal 4000 is made from an FEPmaterial.

FIG. 55 illustrates one embodiment of a sealing system 4100 comprisingmultiple toroidal seals 4102, 4104, 4106 to seal an ultrasonic blade4108 distal of the distal node. The toroidal seals 4102, 4104, 4106 aresuspended by small overmolded features 4110 that do not interfere withthe blade 4108.

FIG. 56 illustrates one embodiment of an end effector assembly 4200comprising a medical forceps having a movable jaw member 4202 in an openposition, an ultrasonic blade 4204, and a slidably movable inner tube4206 including a wiping seal 4208. As illustrated in FIG. 56, theslidably movable inner tube 4206 moves distally in direction 4210 as thejaw member 4212 opens in direction 4212. The wiping seal 4208 surroundsthe blade 4204. As the jaw member 4202 opens in direction 4212 thewiping seal 4208 moves distally in direction 4210 along with the innertube 4206 to wipe surgical matter off the blade 4204.

FIG. 57 illustrates one embodiment of the end effector assembly 4200shown in FIG. 56 comprising a medical forceps having a movable jawmember 4202 in a closed position. As shown in FIG. 57, as the jaw member4202 closes in direction 4216, the inner tube 4206 moves proximally indirection 4214 to retract the wiping seal 4208. To wipe the blade 4204with the wiping seal 4208, the jaw member 4202 is opened as described inconnection with FIG. 56.

FIG. 58 illustrates one embodiment of an end effector assembly 4300comprising a medical forceps having a movable jaw member 4302 in aclosed position shown in solid line and in an open position shown inphantom line, an ultrasonic blade 4304, a slidably movable outer tube4306, and a fixed inner tube 4308 with an overmolded flexible seal 4310located on the inner tube 4308 over the blade 4304.

FIG. 59 illustrates one embodiment of the end effector assembly 4300comprising the movable jaw member 4302 in an open position. As shown inFIG. 59, as the jaw member 4202 is opened the overmolded flexible seal4310 seals the throat 4312 of the device to prevent surgical matter fromentering the space 4314 between the blade 4304 and the inner tube 4308.

Alternate Closure Mechanisms for Ultrasonic Devices

Present ultrasonic devices utilize a tube-in-tube (TnT) closuremechanism to enable closure of the clamp arm, referred to herein as amovable jaw member, against an active length of the ultrasonic blade.The following embodiments of alternate closure mechanisms for ultrasonicdevices may yield several advantages. For example, there may bedifferences among the drag force of actuating the inner tube against theouter tube results in variation in device clamp force. Additionally, thepivot location of the clamp arm on the outer tube causes a sharp angularclosure, and magnifies the impact to a non-uniform closure profile.Furthermore, the predicate device mechanism may be sensitive tovariation in components, as the stackup links the inner and outer tubeat the location of the insulated pin, which currently sits near theproximal end of the tube assembly.

One embodiment of an ultrasonic device comprising an alternate closuremechanism is described hereinbelow in connection with FIGS. 60-62. Inone embodiment, the ultrasonic device comprises a vibrating blade with athrough hole at distal node, an actuator mechanism, an outer tube withcam surfaces at a distal end, and a clamp arm. In another embodiment,the clamp arm is rotatedly fixed to the vibrating blade. In anotherembodiment, the clamp arm is cammed open and closed (against vibratingblade) through relative motion between the outer tube and vibratingblade. In yet another embodiment, one or more pivots of the clamp armare positioned at a distal node of the vibrating blade. An illustrativeexample is discussed hereinbelow.

FIG. 60 is a perspective view of one embodiment of an end effectorassembly 4400 comprising a medical forceps having a movable jaw member4402 and an ultrasonic blade 4404 where the movable jaw member isrotatably attached to a distal node 4406. The outer tube 4412 is showntransparent to show the ultrasonic waveguide 4414 located therein. FIG.61 is a side view of the end effector assembly 4400 shown in FIG. 60with the movable jaw member 4402 in an open position and showntransparent to show outer tube cam slots 4408, 4410 to rotate themovable jaw member 4402 upon relative motion between the blade 4404 andthe outer tube 4412. FIG. 62 illustrates one embodiment of the endeffector assembly 4400 showing the movable jaw member 4402 pivot 4416.

With reference now to FIGS. 60-62, in one embodiment, the movable jawmember 4402 (e.g., clamp arm) is rotatably anchored directly to theblade 4404. The anchoring is accomplished through eliminating the innertube and attaching the movable jaw member 4402 at the most distal node4406 of the blade 4404 so as not to interfere with the acoustical trainof the device. The attachment may be made through the use of a throughhole and insulated pin 4416 attached to the movable jaw member 4402,although other attachment means may be used and are contemplated, suchas, for example, pins, screws, snap fits, overmolds or the like.Additionally, the outer tube 4412 contains a cam surface, which locatesa second pin 4418 attached to the movable jaw member 4402 such that themovable jaw member 4402 rotates about the pivot at pin 4416 in the blade4404 when there is relative motion between the blade 4404 and the outertube 4412. Furthermore, additional geometries for the cam surface arecontemplated, such as splines, curves, and the like. As shown in theembodiment of FIG. 62, the pivot location at pin 4416 is positioned in amore proximal location than current devices. The benefits of anchoringthe movable jaw member 4402 to the blade 4404 at the distal node 4406allows for a more parallel closure along the active portion 4420 of theblade 4404, ultimately creating a more uniform pressure profile. In oneembodiment, the configuration described in connection with FIGS. 60-62operates at lower temperatures and can eliminate the need for apolyimide clamp arm pad within the movable jaw member 4402. Although notshown in the embodiment of FIG. 62, the outer tube 4412 may extendlongitudinally along the axis of the blade, to prevent tissue fromcontacting the non-active blade 4404 surface

Another embodiment of an ultrasonic device comprising an alternateclosure mechanism is described in connection with FIGS. 63-67hereinbelow. The current closure mechanism experiences frictional lossescaused by the relative motion of the inner tube against the outer tubeand the inner tube against the blade overmolds. These frictional lossescan be attributed to decreased tissue feedback experienced by users. Inaddition, the clamp force and pressure profile associated withtube-in-tube closure may be sensitive to component variation. Moreconsistent sealing and transection ability can be achieved either bytighter tolerances or decreasing the number of components involved inclosure. To address these and other issues, in one embodiment theultrasonic device comprises a vibrating blade with a hole through thedistal node, an outer tube, a clamp arm, and a rigid link. In anotherembodiment, the clamp arm is coupled to the vibrating blade with a rigidlink and system of revolute joints. An illustrative example is discussedhereinbelow.

FIG. 63 is a side view of one embodiment of an end effector assembly4500 comprising a medical forceps having a movable jaw member 4502 in aclosed position and an ultrasonic blade 4504. The end effector assembly4500 comprises a linkage 4506 to open and close the movable jaw member4502 by employing relative motion between the outer tube 4508 and theblade 4504. FIG. 64 is a side view of the end effector assembly 4500shown in FIG. 63 with the movable jaw member 4502 in an open position.FIG. 65 is a bottom view of the end effector assembly 4500 shown in FIG.63 with the movable jaw member 4502 in an open position. FIG. 66 is aperspective view of the end effector assembly 4500 shown in FIG. 63 withthe movable jaw member 4502 in an open position. FIG. 67 is aperspective view of the end effector assembly 4500 shown in FIG. 63 withthe movable jaw member 4502 in an open position.

With reference now to FIGS. 63-67, in one embodiment, the linkage 4506may be a four bar linkage configured to actuate the movable jaw member4502 (e.g., clamp arm) by utilizing relative motion between the outertube 4508 and the blade 4504. The inner tube may be replaced with therigid link 4506. The link 4506 may be pinned to the blade 4504 throughthe distal node 4510, although other fastening means are contemplatedsuch as pins, screws, snap fits, and the like. Locating a pin 4512 atthe distal node 4510 minimizes interference to the acoustic train of theultrasonic device. The link 4506 is subsequently pinned to a bottomportion 4514 of the movable jaw member 4502 via pin 4516 and a secondpivot of the movable jaw member 4502 is pinned to an end of the outertube 4508 via pin 4518. Clamping may be achieved by displacing the outertube 4508 forward relative to the blade 4504 in direction 4520. The link4506 component ensures that the distance between the distal node 4510and the lower pivot of the clamp arm remains constant. The presence ofthe link 4506 forces the movable jaw member 4502 to rotate as the outertube 4508 is displaced in direction 4520. In one embodiment, the rigidlink 4506 may comprise a small stainless steel component formed fromprogressive stamping, although other materials and manufacturingprocesses are contemplated, such as metal injection molding (MIM),polymers formed from plastic injection molding, and the like. The use ofa rigid link 4506 also allows simplification of a trigger assembly. Forexample, a trigger assembly for actuating the inner tube may be removed.The use of a four bar linkage 4506 also reduces frictional losses in thetube assembly and results in a decrease in accumulated pressure profilevariations.

Yet another embodiment of an ultrasonic device comprising an alternateclosure mechanism is described in connection with FIGS. 68-70hereinbelow. The embodiment illustrated in FIGS. 68-70 addresses issuessuch as tolerance accumulation between the blade, movable jaw member,inner tube, insulated pin, and rotation knob of existing ultrasonicdevices.

FIG. 68 is a perspective view of one embodiment of an end effectorassembly 4600 comprising a medical forceps having a movable jaw member4602 and an ultrasonic blade 4604 with the movable jaw member 4602 shownin an open position. An inner tube 4608 is translated with respect tothe blade 4604 to open and close the movable jaw member 4602. FIG. 69 isa perspective view of the inner tube 4608 with the outer tube 4606removed. The inner tube 4608 is operatively coupled to the end effectorassembly 4600 shown in FIG. 68. FIG. 70 is a perspective view of a notchportion 4610 of the inner tube 4608 shown in FIG. 69.

With reference now to FIGS. 68-70, in one embodiment, the inner tube4608 is configured to translate with respect to the blade 4604 to movethe movable jaw member 4602 (e.g., clamp arm) and to generate clamppressure against the blade 4604. In the embodiment illustrated in FIGS.68-70, the movable jaw member 4602 is attached and pivots at pivot 4612on the inner tube 4608. The outer tube 4606 translates in direction 4614to pivot the movable jaw member 4602. The inner tube 4608 has a notchedregion 4610 as shown in FIGS. 69 and 70, that is squeezed inwardly intonotches 4616, 4618 formed in the blade 4604 that would be located at thenode location of the blade 4604. In one embodiment, the blade 4604portion in the notched region 4610 location may be coated with a thinlayer of silicone overmold to provide tight relationship between theinner tube 4608 and the blade 4604. Such tight relationship providesgood movable jaw member 4602 clocking with respect to the blade 4604cutting surface 4620 (FIG. 68). As shown in FIG. 68, in one embodiment,a clamp arm pad 4622 also may be provided on the inside portion of themovable jaw member 4602.

FIG. 71 illustrates one embodiment of an end effector assembly 4700comprising a medical forceps having an end effector with a movable jawmember 4702 in a closed position, an ultrasonic blade 4704, and a shaftassembly 4706 configured to counteract deflection of the blade 4704. Acounter deflection element 4720 is provided on an inner tube 4710 at oneof the blade nodes 4718 proximal to the distal node to counteractdeflection of the blade 4704 by the movable jaw member 4702. In oneembodiment, a downward 4712 deflection of the blade 4704 by the movablejaw member 4702 is counteracted by the downward reaction force ofcounter deflection element 4720 at the node 4714 proximal to the distalnode. In one embodiment, the counter deflection element 4720 maycomprise a bulge into the inner lumen to provide downward counter forceto the clamping force. In another embodiment, a window 4708 may be cutinto the inner tube 4710 to allow a downward force to deflect the blade4704 without making contact with the opposing wall of the inner tube4710.

Any of the inner tubes and/or outer tubes disclosed herein may be coatedwith a polymer used as moisture and dielectric barriers. Among them,parylene C may be selected due to its combination of barrier properties,cost, and other processing advantages. Parylene is the trade name for avariety of chemical vapor deposited poly(p-xylylene), for example. Thepolymer coating is used to prevent shorting in the shaft from the bladeto adjacent metal parts. In one embodiment, the just the inner tube(e.g., actuator) may be coated to prevent it from shorting to the bladewhich is one “pole” in the combined ultrasonic and bipolar (RF) device,where the other “pole” is the outer tube and the clamp arm. The innertube insulation provides a more robust and space efficient electricalinsulating barrier than an intervening plastic tube, which may beconsidered an alternative embodiment.

Transducer Support and Limited Rotation with Single Component

In one embodiment, a shaft rotation limiter comprises a single piecewhich interfaces with a transducer flange by a threaded connection. Therotation limiter provides radial support through a component fixed inthe shroud channels. The amount of rotation is limited by the allowedlateral motion of the component in the shroud channels as it is threadedalong the transducer. One example of a shaft rotation limiter isdescribed in connection with FIG. 72 hereinbelow.

FIG. 72 illustrates one embodiment of an ultrasonic transducer 4800having a modified flange 4802 incorporating external threads 4804 toallow transducer rotation. In the illustrated embodiment, the transducerflange 4802 is modified to incorporate external threads 4804. Theexternal threads 4804 may mate with a component 4810 having internalthreads and at least two protruding bosses 4806, 4808. The protrudingbosses 4806, 4808 engage into channels in the device shroud and limittransducer rotation. The component 4810 with the threaded inner diameterinterfaces with the transducer 4800 by threaded connection. Since thecomponent 4810 is limited in transverse travel by the shroud channels,it provides radial support. The component 4810 with the threaded innerdiameter translates rotational movement of the transducer 4800 to alateral motion of the component 4810. Rotation of the blade ortransducer 4800 can be provided by a fixed rotation knob. Rotating theknob may cause the internally threaded component 4810 to translatelaterally and rotation would be limited when the component 4810 can nolonger translate. The lateral movement may be defined by the length ofthe channel in the shroud or the length of the threaded flange 4802 onthe transducer. The shroud allows rotations in excess of 360°. Theamount of rotation of the transducer 4800 is limited by the allowedlateral motion of the component 4810 in the shroud channels (not shown).

Limited Rotation of Ultrasonic Device with Rotation >360°

FIG. 73 is a sectional view of an ultrasonic transducer rotation system4900 comprising a shroud 4902 and a gate 4904 fitted into one-half ofthe shroud 4902. In the illustrated embodiment, the gate 4904 isL-shaped and has two wings 4906A, 4906B (right and left wings,respectively) extending at a fixed angle from a central axis 4908positioned within a portion of the shroud 4902. One additionalcomponent, as well as modifications of a rotation knob and theright-hand or left-hand shroud 4902, allow for approximately 690° ofrotation—almost two full rotations. The rotation knob is used by theoperator to rotate the shaft and ultrasonic transducer of the device.The additional component is referred to herein as the gate 4904. Thegate 4904 is rotationally moveable about axis 4908 within the shroud4902 to two positions. The rotation knob will have an additionalcontoured extrusion element that extends to make contact with the gate4904. Where the gate 4904 is inserted into the shroud 4902 there will bea minimum amount of frictional contact between the shroud 4902 and thegate 4904 to keep the gate 4904 in place while it is not in contact withthe rotation knob. The gate 4904 in the shroud 4902 is constrained by acylindrical hole 4912 and two bosses 4914, 4916 with a slight undercut.The axis 4908 of the gate 4904 that sits in the cylindrical hole 4912would be constrained in part by features on the rotation knob. The gate4904 can be made of a rigid metal or a single stamped metal part orinjection molded from plastic. The gate 4904 can either snap into placein the shroud 4902 or be ultrasonically welded or heat staked to theshroud 4902 in such a fashion to allow free rotation of the gate 4904about axis 4908.

FIGS. 74A-74C illustrate the dynamics of the gate/rotation knobinteraction. FIG. 74A illustrates the gate 4904 in a left-biasedposition such that the rotation knob can be rotated 690° clockwise untila contoured extrusion element 4910 on the rotation knob makes contactwith the right wing 4906A of the gate 4904 so that the left wing 4906Bof the gate 4904 prevents motion by reacting statically against theshroud 4902. Thus, at the starting point, the rotation knob contouredextrusion element 4910 is contacting the outside of the right wing 4906Aof the gate 4904 and is constrained to only move in a counter-clockwisedirection.

FIG. 74B illustrates the rotation knob rotated back 360 degrees until itrotates the right wing 4906A of the gate 4904 into a right-biasedposition. Upon full 360° rotation the rotation knob extrusion 4910contacts the inside of the right wing 4906A of the gate 4904, rotatingthe gate 4904 to the right as the knob rotates around.

FIG. 74C illustrates the rotation knob after it rotates the right wing4906A of the gate 4904 into a right-biased position. Subsequently, therotation knob can be rotated an additional 330° until the contouredextrusion element 4910 of the rotation knob contacts the left wing 4906Bof the gate 4904 and the right wing 4906A of the gate 4904 preventsmotion by reacting statically against the shroud 4902. After 690° ofrotation the rotation knob contacts the outside of the left wing 4906Bof the gate 4904. The right wing 4906A of the gate 4904 is contactingthe shroud 4902 and is therefore stopping further rotation of therotation knob in the counterclockwise direction. This process can bereversed to spin the rotation knob clockwise back to its startingposition.

FIG. 75 is a sectional view of an ultrasonic transducer rotation system4920 comprising a shroud 4922 and a gate 4924 fitted into one-half ofthe shroud 4922, where the rotation system includes a semi-compliantelement. In the illustrated embodiment, the gate 4924 is L-shaped andhas two wings 4926A, 4926B (right and left wings, respectively)extending at a fixed angle from a central axis 4928 positioned within aportion of the shroud 4922. One additional component, as well asmodifications of a rotation knob and the right-hand or left-hand shroud4922, allow for approximately 690° of rotation—almost two fullrotations. The rotation knob is used by the operator to rotate thedevice shaft and ultrasonic transducer. The additional component isreferred to herein as the gate 4924. The gate 4924 is rotationallymoveable about axis 4928 within the shroud 4922 to two positions. Therotation knob will have an additional contoured extrusion element thatextends to make contact with the gate 4924. Where the gate 4924 isinserted into the shroud 4922 there will be a minimum amount offrictional contact between the shroud 4922 and the gate 4924 to keep thegate 4924 in place while it is not in contact with the rotation knob.The gate 4924 in the shroud 4922 is constrained by a cylindrical hole4932 and two bosses 4934, 4936 with a slight undercut. The axis 4928 ofthe gate 4924 that sits in the cylindrical hole 4932 would beconstrained in part by features on the rotation knob. The gate 4924 canbe made of a rigid metal or injection molded from plastic. The gate 4924can either snap into place in the shroud 4922 or be ultrasonicallywelded or heat staked to the shroud 4922 in such a fashion to allow freerotation of gate 4924 about axis 4928.

Unlimited (continuous) rotation of an ultrasonic shear device with anintegrated transducer requires the use of additional components that maynot be cost-effective. One cost-effective solution is to limit rotationof the shaft of the device, thus allowing for a direct-wired connectionbetween the transducer and the hand activation circuit. A tactilebenefit is added to the mechanism that would limit rotation but providetactile feedback before a hard stop is hit. This tactile feedbackelement may enable the user to change the way they use the device,either through rotating their wrist to get additional rotation or tochoose to rotate the device back to a neutral position to ensure theyhave enough rotation to accomplish the task they need to perform.

FIGS. 112A and 112B illustrate one embodiment of an unlimited rotationconnection for an integrated transducer 6216. An unlimited rotationconnection may be provided by the ultrasonic transducer rotation system6220. The ultrasonic transducer rotation system 6220 may comprise, forexample, a male plug 6222 and a female receptacle 6224. The male plug6222 may be configured to freely rotate within the female receptacle6224 while maintaining an electrical connection between the ultrasonictransducer 6216 and, for example, power system 6248. For example, in oneembodiment, the male plug 6222 and the female receptacle 6224 maycomprise a stereo plug and jack. FIG. 112A illustrates the male plug6222 and the female receptacle 6224 in an uncoupled, or unmated,position. FIG. 112B illustrates the male plug 6222 and the femalereceptacle 6224 in a coupled, or mated, position. In the mated position,the male plug 6222 is able to freely rotate within the female receptaclewhile maintaining an electrical connection between the male plug 6222and the female receptacle 6224.

FIGS. 113A-113C illustrate one embodiment of an unlimited rotationconnection 6520. The unlimited rotation connection 6520 comprises a maleplug 6522 and a female receptacle 6524. The male plug 6522 may comprisea plurality of electrodes 6526 a-d coupled to an insulating tube 6528.The male plug 6522 may be coupled to a shaft/transducer assembly and mayrotate in unison with the shaft/transducer assembly. In someembodiments, the first and second electrodes 6526 a-6526 b may becoupled to the transducer. In some embodiments, the third and fourthelectrodes 6526 c-6526 d may be coupled to bipolar electrodes located atan end effector. In some embodiments, such as a monopolar electrodearrangement, the fourth electrode 6526 d may be omitted. The pluralityof electrodes 6526 may each be coupled to a wire 6530 a-6530 d. Thefemale receptacle 6524 may comprise a plurality of helical contacts 6532a-6532 d. The plurality of helical contacts 6532 a-6532 d may bepositioned such that each of the helical contacts 6532 a-6532 d iselectrically coupled to a corresponding electrode 6526 a-6526 d on themale plug 6522 when the male plug 6522 is inserted into the femalereceptacle 6524. FIG. 113B illustrates a cross-sectional view of thefemale receptacle 6524 take along line B-B. The female receptacle 6524comprises a individual helical contacts 6532 a-6532 d separated byinsulators 6534 a-6534 c. FIG. 113C illustrates the individual helicalcontact profile of a helical contact 6532 a. The helical contact 6532 amay comprise a first metal plate 6536 a and a second metal plate 6536 b.A plurality of twisted wires 6538 may be spirally twisted to assurecontact between the male plug 6522 and the metal plates 6536 a, 6536 b.In some embodiments, the direction of the spiral may be alternated toprovide increased connectivity in all directions of rotation. Thetwisted wires 6538 may comprise a hyperbolic shape.

The tactile feedback element is added to the limited rotation mechanismshown in FIGS. 73-74C, which includes on the rotation knob an additionalcontoured extrusion element 4930 that extends to make contact with thegate 4924 (the mechanism that limits rotation). In the embodimentillustrated in FIGS. 75-76C, a contoured extrusion element 4930 (FIGS.76A-76C) located on the rotation knob can be made of a semi-compliantmaterial. Alternatively, portions of contoured extrusion element 4930indicated by elements 4938, may be comprised of a semi-compliantmaterial. The semi-compliant material could be made of rubber, medium tohigh density rubber, silicone, thermoplastic elastomers, springy pieceof stainless steel, spring steel, copper, shape memory metals, and thelike. Any of these materials can be insert molded or mechanicallyconnected to the rotation knob.

The purpose of the contoured extrusion element 4930 (FIGS. 76A-76C) onthe rotation knob is to contact the gate 4924 to provide the motionneeded for the gate 4924 to function. Adding compliance to the contouredextrusion element 4930 rotation knob feature enables the user to feelthat they are approaching the hard stop a few degrees of rotation beforethe hard stop is contacted. This feedback may enable the user to changethe way they use the device, either through rotating their wrist to getadditional rotation or to choose to rotate the device back to a neutralposition to ensure they have enough rotation to accomplish the task theyneed to perform.

FIGS. 76A-76C illustrate the dynamics of the gate interaction with arotation knob, where the rotation knob comprises a tactile feedbackelement. FIG. 76A illustrates the gate 4924 in a left-biased positionsuch that the rotation knob can be rotated 690° clockwise until acontoured extrusion element 4930 on the rotation knob makes contact withthe right wing 4906A of the gate 4924 so that the left wing 4926B of thegate 4924 prevents motion by reacting statically against the shroud4922. Thus, at the starting point, the rotation knob contoured extrusionelement 4930 is contacting the outside of the right wing 4926A of thegate 4924 and is constrained to only move in a counter-clockwisedirection. A layer of (insert-molded) semi-compliant material 4938 maybe located on either side or both sides of the contoured extrusionelement 4930. The semi-compliant material 4938 could be made of rubber,medium to high density rubber, silicone, thermoplastic elastomers,springy piece of stainless steel, spring steel, copper, shape memorymetals, and the like. Any of these semi-compliant materials 4938 can beinsert molded or mechanically connected to the rotation knob.

FIG. 76B illustrates the rotation knob rotated back 360 degrees until itknocks the right wing 4926A of the gate 4924 into a right-biasedposition. Upon full 360° rotation the contoured extrusion element 4930of the rotation knob contacts the inside of the right wing 4926A of thegate 4924, rotating the gate 4924 to the right as the knob rotatesaround. The semi-compliant material 4938 provides tactile feedback tothe user.

FIG. 76C illustrates the rotation knob after it rotates the right wing4926A of the gate 4924 into a right-biased position. Subsequently, therotation knob can be rotated an additional 330° until the contouredextrusion element 4930 of the rotation knob contacts the left wing 4926Bof the gate 4924 and the right wing 4926A of the gate 4924 preventsmotion by reacting statically against the shroud 4922. After 690° ofrotation the rotation knob contacts the outside of the left wing 4926Bof the gate 4924. The right wing 4926A of the gate 4924 is contactingthe shroud 4922 and is therefore stopping further rotation of therotation knob in the counterclockwise direction. This process can bereversed to spin the rotation knob clockwise back to its startingposition. The semi-compliant material 4938 provides tactile feedback tothe user. The semi-compliant material 4938 tactile feedback element matenable the user to change the way they use the device, either throughrotating their wrist to get additional rotation or to choose to rotatethe device back to a neutral position to ensure they have enoughrotation to accomplish the task they need to perform.

RF Spot Coagulation with Integrated Ultrasonic/RF Generator

FIG. 77 illustrates an integrated RF/ultrasonic instrument 5000electrically connected such that an ultrasonic blade/horn 5002 iselectrically connected to a positive lead 5006 of an ultrasonicgenerator 5004 and is also coupled to an RF generator to provide spotcoagulation by applying RF energy to tissue 5018. The integratedRF/ultrasonic instrument 5000 enables the touch up of diffuse bleeding(capillary bleeding, cut site oozing) without the need for ultrasoniccoupling pressure. Further, the coupling pressure needed for ultrasonicinstruments, to couple the blade to tissue such that friction-basedtissue effect is effective, is relatively high which results in (1)difficulty in applying enough pressure to generate hemostatic effect inloosely supported (i.e., un-clamped) tissue or (2) coupling pressurethat generates too much tissue disruption that, in many cases, makes thediffuse bleeding worse.

In one embodiment, the integrated RF/ultrasonic instrument 5000 is wiredsuch that the horn/blade 5002 is directly connected to the positive lead5006 of the generator 5004. Conventional ultrasonic devices are wiredsuch that the negative/return lead is connected to the horn/blade. Aswitch 5010 is provided to enable two device functionalities (1)ultrasonic and (2) bipolar (RF) to be performed. The first state of theswitch 5010 connects the negative/return lead 5008 to the piezoelectrictransducer (PZT) stack 5020 such that the generator 5004 drives the PZTstack 5020. The second state of the switch 5010 isolates the PZT stack5020 and connects the negative/return 5008 to the device tube 5016 and amovable jaw member 5022 (e.g., clamp arm) through an electricalconductor 5014 and allows the generator 5004 signal to be driven throughtissue 5018 located between the blade 5002 and the clamp arm 5022. Theresistance in the tissue 5018 seals the vessels. Feedback signals alsomay be provided back to the generator 5004 to adjust signal parameters(e.g., amplitude, frequency, pulsing, modulation, etc.)

In one embodiment, the integrated RF/ultrasonic instrument 5000 maycomprise a sealing button, wherein, when pressed, the generator 5004 mayproduce bipolar RF energy through the handpiece and into the ultrasonicblade 5002 and return through the clamp arm 5022. In one embodiment, theelectrical RF current may travel around the outside of the blade 5002and create a robust bi-polar seal. The duration of the bipolar RF energymay be about one second, after which an algorithm may cause thegenerator 5004 to switch to the ultrasonic power curve, wherein theblade 5002 would be activated and the cut completed in the middle of twoRF seals.

Ultrasonic cutting also may provide some sealing. The application of RFenergy provides added confidence that there is an RF seal in place oneach side of the blade 5002.

In one embodiment, the RF/ultrasonic device comprises a blade or clamparm or both with the distal end coated with thermally and electricallyinsulative material, wherein a distal end of the blade or clamp arm orboth may have varying degrees of exposed (uncoated) areas that will beapplication dependent. In another embodiment, the exposed area on theblade or clamp arm or both may vary depending on application and may beeither symmetrical or asymmetrical. In another embodiment, the exposedarea on the blade may comprise at least one exposed area/segmentseparated by at least one coated segment. In one embodiment, a processof masking the blade or clamp arm or both to generate exposed area isprovided. Alternatively, coating may be selectively removed to producethe same desired effect. Specific embodiments of such coated blades aredescribed hereinbelow in connection with FIGS. 80-95.

FIG. 78 illustrates one embodiment of an integrated RF/ultrasonicinstrument 5030 electrically connected to an energy source such as agenerator 5032 comprising four-lead jack connector 5046 is mated with aslidable female mating plug 5048. FIG. 79 is a detail view of thefour-lead jack connector 5046 mated with a slidable female mating plug5048 coupled to an ultrasonic transducer 5034. With reference to FIGS.78-79, in one embodiment, the generator 5032 may comprise a firstultrasonic energy source such as ultrasonic generator 5040 and a secondRF energy source such as an RF generator 5044 either individually orintegrated into the same housing. An ultrasonic transducer 5034 iselectrically connected to positive and negative leads 5036 (H+), 5038(H−) of the ultrasonic generator 5040. A monopolar positive lead 5042(M+) is coupled to the RF generator 5044. A four-lead jack connector5046 is mated with a slidable female mating plug 5048 to electricallyengage either 1) connection of the ultrasonic generator 5040 leads 5036,5038 to the ultrasonic transducer 5034 or 2) connection of the monopolarRF generator 5044 lead 5042 to the transducer 5034 to prevent connectingboth the ultrasonic generator 5040 and the monopolar RF generator 5044to the transducer 5034 at the same time. In one embodiment, the femaleconnector may be integrated in the device and the four lead jack may bemated to a generator.

A slidable switch 5074 comprises a slidable female connector 5048configured to receive a rotatable jack connector 5046. The rotatablejack connector 5046 is used for mating with the slidable femaleconnector 5048 for providing an electrical connection between twoelectrical devices, such as the transducer 5034 and the generator 5032.Referring particularly to FIG. 79, the rotatable jack connector 5046comprises a tip terminal portion 5064 at a front end thereof, a groundterminal portion 5052 at a rear end thereof and two intermediateterminal portions 5056, 5060 to the tip and ground terminal portions5064, 5052. The terminal portions 5052, 5056, 5060, 5064 areelectrically separated from each other by dielectric insulators 5054.The ground terminal portion 5052 connects with a connecting portion of5046. Since the structure of the rotatable mating plug 5046 is wellknown by those skilled in the art, detailed description thereof isomitted here. Conductive terminal portions 1, 2, 3, 4 are electricallyconnected to terminal portions 5052, 5056, 5060, 5064. Conductiveterminal portions 1 and 2 connected to terminal portions 5052, 5056 andare isolated and are not coupled to the transducer 5034. Conductiveterminal portions 3 and 4 are electrically connected to terminalportions 5060, 5064 and are electrically connected to the transducer5034.

In one embodiment, the slidable female connector 5048 is slidablebetween Position 1 and Position 2. Position 1 may be configured tocorrespond with ultrasonic mode of operation and Position 2 may beconfigured to correspond with monopolar mode of operation. In Position1, the monopolar RF lead 5042 (M+) from the monopolar RF generator 5044is disconnected physically from the transducer 5034. The slidable femaleconnector 5048 comprises contact portions 5066, 5068, 5070, 5072configured to electrically engage terminal portions 5052, 5056, 5060,5064. The slidable female connector 5048 includes an actuator portion5074 that enables the user to slide the slidable female connector 5048between multiple positions. As shown in particular in FIG. 79, theslidable female connector 5048 is slidably movable between Position 1and Position 2, ultrasonic and monopolar RF modes.

Moving the slidable female connector 5048 into Position 1 places theintegrated RF/ultrasonic instrument 5030 in ultrasonic mode. In thisposition, the contact portions 5066, 5068 are electrically engaged withterminal portions 5060, 5064 thereby electrically coupling positive andnegative leads 5036 (H+), 5038 (H−) of the ultrasonic generator 5040 tothe transducer 5034 through conductive terminal portions 3 and 4. Inposition 1, the monopolar positive lead 5042 (M+) coupled to the RFgenerator 5044 is physically disconnected from the transducer 5034.

Moving the slidable female connector 5048 into Position 2 places theintegrated RF/ultrasonic instrument 5030 in monopolar RF mode. In thisposition, the contact portions 5066, 5068 are electrically engaged withterminal portions 5052, 5056 thereby electrically coupling positive andnegative leads 5036 (H+), 5038 (H−) of the ultrasonic generator 5040 toisolated conductive terminal portions 1 and 2, effectively disconnectingthe ultrasonic generator 5040 from the transducer 5034. In position 2,contact portion 5070 electrically engages terminal portion 5060 therebyelectrically coupling the monopolar positive lead 5042 (M+) of the RFgenerator 5044 to the transducer 5034 through conductive terminalportion 3. Contact portion 5072 electrically engages terminal tipportion 5064, which is electrically isolated, or open.

FIGS. 114A and 114B illustrate one embodiment of an integratedRF/ultrasonic surgical instrument, for example, the integratedRF/ultrasonic surgical instrument 5030, comprising an integratedRF/ultrasonic end effector 6304. The integrated RF/ultrasonic endeffector 6304 may be configured to deliver RF energy and/or ultrasonicenergy to a tissue section. FIG. 114A illustrates a clamping arm 6364 inan open position. An ultrasonic blade 6366 is positioned such that theclamping arm 6364 and the ultrasonic blade 6366 may clamp tissuetherebetween. The ultrasonic blade 6366 is positioned within a heatshield 6322. FIG. 114B illustrates the integrated RF/ultrasonic endeffector 6304 in a clamped position.

FIGS. 115A-115I illustrate various embodiments of a cross-section of theintegrated RF/ultrasonic end effector 6304 taken along line A-A. As canbe seen in FIGS. 115A-115I, RF electrodes 6370, 6372 may be located onand/or comprise any suitable portion of the integrated RF/ultrasonic endeffector 6304. FIGS. 115A-115F illustrates various embodiments of theintegrated RF/ultrasonic end effector 6304 comprising a bipolarelectrode arrangement. For example, FIG. 115A illustrates one embodimentof the integrated RF/ultrasonic end effector 6304 a. Positive electrodes6370 a, 6372 b may be located on the tissue-facing portion of the clamppad 6368. The clamp arm 6364 a may comprise a return, or negative,electrode. FIG. 115B illustrates one embodiment of the integratedRF/ultrasonic end effector 6304 b. The positive electrodes 6370 b, 6372b are located on the heat shield 6322. An insulator 6374 may be locatedbetween the positive electrodes 6370 a, 6370 b and the heat shield 6322to insulate heat shield 6322. The clamp arm 6364 may function as thereturn electrode. FIG. 115C is similar to FIG. 115A, with the exceptionthat the clamp arm 6364 c extends laterally beyond the insulting clamppad 6368 c. FIG. 115D is similar to FIG. 115B, with the exception thatthe clamp arm 6364 d extends laterally beyond the insulating clamp pad6368 d. In FIG. 115E, the clamp pad 6368 e comprises a positiveelectrode 6370 e and a negative electrode 6372 e. In FIG. 115F, the heatshield 6322 f comprises the positive electrode 6370 f and the negativeelectrode 6372 f.

FIGS. 115G-115I illustrate various embodiments of the integratedRF/ultrasonic end effector 6304 comprising a monopolar electrode. InFIG. 115G, the ultrasonic blade 6366 g comprises a monopolar electrodefor delivering RF energy to a tissue section. In FIG. 115H, the clamparm 6364 h comprises the monopolar electrode. In FIG. 115I, the heatshield 6322 i comprises the monopolar electrode.

FIGS. 117-118 illustrate one embodiment of an integrated RF/ultrasonicsurgical instrument 6602. The integrated RF/ultrasonic instrument 6602may comprise an insulated shaft 6614. The shaft 6614 and end effector6604, including the jaw 6664 and ultrasonic blade 6666, may be energizedwith monopolar RF energy. The monopolar RF energy may be controlled by adouble pole double throw (DPDT) selector switch 6620 located, forexample, on the handle 6612 of the integrated RF/ultrasonic instrument6602. The DPDT selector switch 6628 may switch the integratedRF/ultrasonic instrument 6602 from an ultrasonic generator 6620 to amonopolar RF generator 6622. FIG. 118 illustrates one embodiment of aDPDT selector switch 6628 which may be configured to switch between theultrasonic generator 6620 and the monopolar RF generator 6622. The DPDTselector switch 6628 may comprise a user toggle 6630.

Coated Ultrasonic/RF Blades

FIGS. 80-83 illustrate various views of an ultrasonic blade 5100 coatedwith an electrically insulative material 5102 to provide thermalinsulation at the tissue contact area to minimize adhesion of tissue tothe blade 5100. Conventional ultrasonic devices utilize one mode oftreatment, which limits versatility. For example, conventionalultrasonic devices may be used for blood vessel sealing and transectingtissue. Bipolar RF may offer added benefits such as a method for spotcoagulation and pretreatment of tissue. Incorporating ultrasonic and RFmay provide versatility and increase effectiveness. However,conventional ultrasonic devices utilize coatings to provide insulationat the distal end of the blade. These coatings are electricallyinsulative, and therefore limit current flow thus decreasing RFeffectiveness. Additionally, current density may influenceeffectiveness. It may be contemplated that the entire waveguide of theblade may be coated with such coating to prevent shorting of the bladeto the tube assembly return path. It is also contemplated that a similarcoating and masking procedure may be employed in the clamp arm in orderto provide a suitable path for current flow. In order to incorporateboth energy modes into one device, a masking process for blade tipcoating or coating removal process may be required. Creating an exposedarea on the surface of the blade may provide a suitable path for currentflow.

Accordingly, in one embodiment, an ultrasonic blade 5100 comprises alubricious coating 5102 having properties similar to Teflon on thedistal end of the blade 5100 as shown in FIGS. 80-83. The use of RF as amode of treatment requires current to flow from the blade 5100, throughtissue, and to a movable jaw member generally referred to as a clamparm. The coating 5102 is used to provide thermal insulation at thecontact area and minimize adhesion of tissue to blade 5100. However, thecoating 5102 also is electrically insulative, which limits the amount ofcurrent flow. A method of masking the blade 5100 or removing coatingselectively may be used to create exposed surfaces. In otherembodiments, the lubricious coating 5102 provided on the blade 5100 mayextend proximally so as to could coat the whole blade 5100, for example.In one embodiment, the blade 5100 may be coated back to the distal node.

FIGS. 84-93 illustrate various ultrasonic blades partially coated withan electrically insulative material to provide thermal and electricalinsulation at the tissue contact area to minimize adhesion of tissue tothe blade, where the lighter shade regions 5202 of the blade representthe coated portions and the darker shaded regions 5204 of the bladerepresent exposed surfaces that enable RF current to flow from theexposed region of the blade, through the tissue, and the movable jawmember. The exposed surface is symmetrical. The area on the blade thatrequires and exposed surface may be application dependent. Therefore, adifferent percentage of coating/exposed area has been illustrated isFIGS. 84-93. However, the embodiments are not limited to only theillustrated coverage. Although the embodiments shown in connection withFIGS. 84-93 show height-wise variation in electrically insulative bladecoating, the lighter shaded regions 5202, it is contemplated within thescope of the present disclosure lengthwise variation in electricallyinsulative blade coating, the lighter shaded regions 5202, such that aportion of the distal tip of the blade exposed. In one example, thedistal ⅓ of the sides of the blade would be exposed.

FIGS. 94-95 illustrate two ultrasonic blades with non-symmetricalexposed surfaces, where the blades are coated with an electricallyinsulative material to provide thermal insulation at the tissue contactarea to minimize adhesion of tissue to the blade, where the lightershade regions 5302 of the blade represent the coated portions and thedarker shaded regions 5304 of the blade represent exposed surfaces thatenable RF current to flow from the exposed region of the blade, throughthe tissue, and the movable jaw member. Current density may impactfunctionality and may be controlled by providing different surfaceareas. The surface areas do not have to be symmetrical on each side ofthe blade tip and may differ depending on performance. In addition, theexposed area may consist of two or more segments that are separated byat least one coated segment (not illustrated). Other coated/exposedgeometries are possible as well, such as varying the depth or width ofthe exposed area along the axis of the blade.

In another embodiment, the blade and/or the tube assembly may beelectrically charged to repel surgical matter.

FIGS. 119A-119E illustrate various embodiments of integratedRF/ultrasonic surgical end effectors. The clamp arm may comprise, forexample, a circular clamp arm 6764 a, 6764 b, a hook clamp arm 6764 c, acircular clamp arm comprising a cavity 6764 d, or a curved hook clamparm 6764 e. The ultrasonic blade may comprise, for example, arectangular ultrasonic blade 6766 a, 6766 c and/or an ellipticalultrasonic blade 6766 b. FIGS. 120A-120C illustrate various embodimentsof bipolar integrated RF/ultrasonic end effectors. In one embodiment,the clamp arm 6864 a may comprise first electrode and the ultrasonicblade 6866 a may comprise a second electrode. The clamp arm 6864 a orthe ultrasonic blade 6866 a may comprise a return electrode. In someembodiments, the clamp arm 6864 b may comprise an insulating pad 6868 toseparate the clamp arm 6864 b from the ultrasonic blade 6866 b. In someembodiments, the clamp arm 6864 c may comprise both a first electrode6870 and a second electrode 6872. The first and second electrodes 6870,6872 may be separated by an insulating portion of the clamp arm 6864 c.

FIGS. 121A-121C comprise various embodiment of monopolar integratedRF/ultrasonic end effectors. In some embodiments, the entire clamp arm6964 a may comprise a monopolar electrode. In some embodiments, theclamp arm 6964 b may comprise an insulating pad 6968. A portion of theclamp arm 6964 b may comprise a monopolar electrode. In someembodiments, the clamp arm 6964 c and an ultrasonic blade 6966 maycomprise a single monopolar electrode.

Heat Shielded Ultrasonic Blades

FIG. 96 is a perspective view of one embodiment of an ultrasonic endeffector 5400 comprising a metal heat shield 5402. The ultrasonic endeffector 5400 comprises a clamp arm 5410. The clamp arm 5410 comprises amovable jaw member 5408 (clamp arm), a tissue pad 5412, an ultrasonicblade 5404, and a heat shield 5402 provided at a distance from theultrasonic blade 5404. The heat shield 5402 is metal and containsapertures 5406 for air flow which provides cooling to the heat shield5402 and the ultrasonic blade 5404. The heat shield 5402 is disposedopposite of the movable jaw member 5408.

FIG. 97 is a perspective view of another embodiment of an ultrasonic endeffector 5420 comprising a retractable metal heat shield 5422. Theultrasonic end effector 5420 comprises a clamp arm 5430. The clamp arm5430 comprises a movable jaw member 5428, a tissue pad 5432, anultrasonic blade 5424, and a heat shield 5422 provided at a distancefrom the ultrasonic blade 5424. In another embodiment, the metal heatshield 5422 is attachable to the ultrasonic blade 5424 at the distalmost node location. The attachment means also acts as a heat sink 5422to remove heat from the blade 5424. The heat shield 5422 is metal andcontains apertures 5426 for air flow which provides cooling to the heatshield 5422 and the ultrasonic blade 5424. The heat shield 5422 isdisposed opposite of the movable jaw member 5428.

FIG. 98 is a side view of another embodiment of an ultrasonic endeffector 5440 comprising a heat shield 5444 shown in cross-section. Theultrasonic end effector 5440 comprises a clamp arm 5448. The clamp arm5448 comprises a movable jaw member 5252, an ultrasonic blade 5450, anda heat shield 5444 that also acts as a heat sink 5442. A pad 5452 may beprovided on the blade 5450 side of the movable jaw member 5252 to grasptissue between the pad 5452 and the blade 5450. The attachment of theheat shield 5444/heat sink 5442 is at a node location. FIG. 99 is afront view of the ultrasonic end effector 5440 shown in FIG. 98,according to one embodiment.

FIGS. 100-104 illustrate various views of one embodiment of anultrasonic end effector 5460 comprising a dual purpose rotatable heatshield 5462. FIG. 100 illustrates one embodiment of a clamp arm 5464comprising a movable jaw member 5464 shown in a closed position and adual purpose rotatable heat shield 5462 located below an ultrasonicblade 5468. The ultrasonic end effector 5460 comprises a clamp arm 5464having a movable jaw member 5470, an ultrasonic blade 5468, and the dualpurpose rotatable heat shield 5462. In one embodiment, the clamp arm5464 comprises a movable jaw member 5470, which is shown in FIG. 100 ina closed position, and the rotatable heat shield 5462 is located belowthe ultrasonic blade 5468. In this embodiment, the heat shield 5462 isdual purposed and is rotatable about the blade 5468. The blade 5468 inthis example is a straight/non-curved configuration. While the heatshield 5468 is disposed opposite of the movable jaw member 5470 (shearstype end-effector), it acts as a heat shield 5462. After rotation aboutthe blade 5468, the heat shield 5462 now is disposed between the blade5468 and the movable jaw member 5470 providing a tissue clampingsurface, backed by the blade 5468 providing strength/support for theheat shield 5468. Also, the heat shield 5468 may be configured toprovide energy opposite of the energy that may be provided on themovable jaw member 5470 creating a bi-polar energy that may effecttissue.

FIG. 101 illustrates one embodiment of a movable jaw member 5470 shownin an open position and a dual purpose rotatable heat shield 5462rotated such that it is interposed between the movable jaw member 5470and the blade 5468.

FIG. 102 illustrates an end view of one embodiment of a dual purposerotatable heat shield 5462 rotated in a first position. FIG. 103illustrates an end view of one embodiment of the dual purpose rotatableheat shield 5462 rotated in a second position. With reference now toFIGS. 102-103, the rotatable heat shield 5462 has purposeful alignmentthat enables a tapered portion of the shield 5642 to come in between thetop of the blade 5468 surface and the movable jaw member 5470. Thisrotation enables “back cutting” if necessary while still allowing normalactivation shielding. Additionally an inner contour of the shield 5462may be configured for contact to “clean” the tip upon rotation ifnecessary. Further if the shield 5462 is insulated, rotation of theshield 5462 from the stage 1 position into the stage 2 position enablesRF energy to be applied for sealing only. Bottom surface of shield couldhave grip to assist in grasping as well when rotated to position 2.

FIG. 104 is a top profile view of one embodiment of a heat shield 5462showing a tapered portion of the shield 5462. As shown, in oneembodiment the heat shield 5462 includes a tapered portion defined byradius R1 relative to radius R2, where R2>R1.

FIGS. 116A-116B illustrates one embodiment of a cooling system for anultrasonic surgical instrument. Air 6416 may be forced down an innertube 6406 of the ultrasonic surgical instrument 6302 and over anultrasonic end effector 6404. The air movement over the ultrasonic endeffector 6304 may cool the ultrasonic end effector 6404. In oneembodiment, cold air may be used to increase the cooling of the endeffector 6404. Air 6416 may be moved in the direction of shown to coolthe ultrasonic end effector 6404 through convection heat transfer fromthe ultrasonic end effector 6404 to the air. In some embodiments, ahospital air-line 6410 may be coupled to the ultrasonic instrument 6302to provide compressed air flow through the inner tube 6406. In someembodiments, a hand pump 6412 and a reservoir 6414 may be located in theproximal end of the surgical instrument 6402, such as, for example, inthe handle. A clinician may operate the hand pump 6412 to generate airpressure within the reservoir 6414. The hand pump 6412 may comprise, forexample, a squeeze bulb. The reservoir 6414 and/or the hospital air-line6410 may be force air over the ultrasonic end effector 6404 with eachopening and/or closing of the jaws. In some embodiments, the reservoir6414 and/or the hospital air-line 6410 may provide a continuous flow ofair over the ultrasonic end effector. In some embodiments, the innertube 6406 may comprise a vortex tub, illustrated in FIG. 116B. Thevortex tube may facilitate movement of air 6416 within the inner tube6406 to travel distally 6418 through the inner tube 6406, over theultrasonic end effector 6404, and return 6420 to the proximal end of theinner tube 6406 which may be open to release the air. The distal end ofthe vortex tube may comprise a splitter to split the stream of air 6418to cool the distal end of the ultrasonic end effector 6404.

Ultrasonic 4-Bar Closure with Application to an Ultrasonic Rongeur

FIG. 105 illustrates a conventional rongeur surgical instrument 6000.Certain orthopedic procedures such as spinal fusion are used to treatdegenerative spinal disk disease. One of the most commonly usedinstruments is the rongeur 6000 as shown in FIG. 105 for the removal ofthe spinal disk, which is made up of a nucleus and a tough annulus. Therongeur 6000 uses a 4-bar linkage in combination with a clamp arm 6002comprising a movable jaw member 6004 to take bites of the spinal diskmaterial. Generally speaking, a number of bites (10 to 20) may be takenfor complete removal of the spinal disk. The multiple use of the rongeur6000 can be fatiguing.

Accordingly, FIG. 106 illustrates one embodiment of an ultrasonic energydriven rongeur device 6100. The ultrasonic energy driven rongeur device6100 comprises an ultrasonic transducer 6102 is added to one member of a4-bar mechanism. The rongeur device 6100 also comprises two elongatehorizontal members. As shown in FIG. 106, only the lower horizontalmember 6104 coupled to a handle 6106 is shown. The two elongatehorizontal members of the ultrasonic rongeur device 6100 are eachattached to one handle 6106 of the ultrasonic rongeur device 6100. Thehorizontal members are connected with a small link at a distal end 6103,and the forward handle 6106 is the second link. These four membersapproach parallel-rules. As can be seen in FIG. 106, the bottomhorizontal member 6104 is basically a straight rod which does not move.In accordance with one embodiment of the present disclosure, by placingpivots 6108, 6110 of the lower horizontal member 6104 at Nodes, thelower horizontal member 6104 may be considered an ultrasonic waveguide.Accordingly, the rest of the rongeur device 6100 is attached to thelower horizontal arm 6104 at nodes. The proximal end of the lowerhorizontal member 6104 can be attached to an ultrasonic transducer 6102to produce ultrasonic displacement at the distal end 6103. The amplitudeof the ultrasonic displacement will aid in cutting the tissue andtherefore reduce the force required by the surgeon. Not shown here isthe need to insert some damping material between the two horizontalmembers and a sheath on the lower horizontal member 6104 to avoidcontact with intervening tissue. Advantages of the ultrasonic drivenrongeur device 6100 include, without limitation, a novel closuremechanism for ultrasonic instruments based on a 4-bar linkage, lowerforce required to take a bite of spinal disk material, reduce surgeonfatigue, and novel instrument architecture for additional applications.

While various details have been set forth in the foregoing description,it will be appreciated that the various aspects of the ultrasonic andelectrosurgical devices may be practiced without these specific details.For example, for conciseness and clarity selected aspects have beenshown in block diagram form rather than in detail. Some portions of thedetailed descriptions provided herein may be presented in terms ofinstructions that operate on data that is stored in a computer memory.Such descriptions and representations are used by those skilled in theart to describe and convey the substance of their work to others skilledin the art. In general, an algorithm refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities which may, though need notnecessarily, take the form of electrical or magnetic signals capable ofbeing stored, transferred, combined, compared, and otherwisemanipulated. It is common usage to refer to these signals as bits,values, elements, symbols, characters, terms, numbers, or the like.These and similar terms may be associated with the appropriate physicalquantities and are merely convenient labels applied to these quantities.

Unless specifically stated otherwise as apparent from the foregoingdiscussion, it is appreciated that, throughout the foregoingdescription, discussions using terms such as “processing” or “computing”or “calculating” or “determining” or “displaying” or the like, refer tothe action and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

It is worthy to note that any reference to “one aspect,” “an aspect,”“one embodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with the aspect isincluded in at least one aspect. Thus, appearances of the phrases “inone aspect,” “in an aspect,” “in one embodiment,” or “in an embodiment”in various places throughout the specification are not necessarily allreferring to the same aspect. Furthermore, the particular features,structures or characteristics may be combined in any suitable manner inone or more aspects.

Some aspects may be described using the expression “coupled” and“connected” along with their derivatives. It should be understood thatthese terms are not intended as synonyms for each other. For example,some aspects may be described using the term “connected” to indicatethat two or more elements are in direct physical or electrical contactwith each other. In another example, some aspects may be described usingthe term “coupled” to indicate that two or more elements are in directphysical or electrical contact. The term “coupled,” however, also maymean that two or more elements are not in direct contact with eachother, but yet still co-operate or interact with each other.

Although various embodiments have been described herein, manymodifications, variations, substitutions, changes, and equivalents tothose embodiments may be implemented and will occur to those skilled inthe art. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications and variations as falling within the scope of thedisclosed embodiments. The following claims are intended to cover allsuch modification and variations.

Some or all of the embodiments described herein may generally comprisetechnologies for ultrasonic and RF treatment of tissue, or otherwiseaccording to technologies described herein. In a general sense, thoseskilled in the art will recognize that the various aspects describedherein which can be implemented, individually and/or collectively, by awide range of hardware, software, firmware, or any combination thereofcan be viewed as being composed of various types of “electricalcircuitry.” Consequently, as used herein “electrical circuitry”includes, but is not limited to, electrical circuitry having at leastone discrete electrical circuit, electrical circuitry having at leastone integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment). Those having skill in the art will recognize that thesubject matter described herein may be implemented in an analog ordigital fashion or some combination thereof.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment,several portions of the subject matter described herein may beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, those skilled in the art willrecognize that some aspects of the embodiments disclosed herein, inwhole or in part, can be equivalently implemented in integratedcircuits, as one or more computer programs running on one or morecomputers (e.g., as one or more programs running on one or more computersystems), as one or more programs running on one or more processors(e.g., as one or more programs running on one or more microprocessors),as firmware, or as virtually any combination thereof, and that designingthe circuitry and/or writing the code for the software and or firmwarewould be well within the skill of one of skill in the art in light ofthis disclosure. In addition, those skilled in the art will appreciatethat the mechanisms of the subject matter described herein are capableof being distributed as a program product in a variety of forms, andthat an illustrative embodiment of the subject matter described hereinapplies regardless of the particular type of signal bearing medium usedto actually carry out the distribution. Examples of a signal bearingmedium include, but are not limited to, the following: a recordable typemedium such as a floppy disk, a hard disk drive, a Compact Disc (CD), aDigital Video Disk (DVD), a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.), etc.).

All of the above-mentioned U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications, non-patent publications referred to in this specificationand/or listed in any Application Data Sheet, or any other disclosurematerial are incorporated herein by reference, to the extent notinconsistent herewith. As such, and to the extent necessary, thedisclosure as explicitly set forth herein supersedes any conflictingmaterial incorporated herein by reference. Any material, or portionthereof, that is said to be incorporated by reference herein, but whichconflicts with existing definitions, statements, or other disclosurematerial set forth herein will only be incorporated to the extent thatno conflict arises between that incorporated material and the existingdisclosure material.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically matable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory).

A sale of a system or method may likewise occur in a territory even ifcomponents of the system or method are located and/or used outside theterritory. Further, implementation of at least part of a system forperforming a method in one territory does not preclude use of the systemin another territory.

Although various embodiments have been described herein, manymodifications, variations, substitutions, changes, and equivalents tothose embodiments may be implemented and will occur to those skilled inthe art. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications and variations as falling within the scope of thedisclosed embodiments. The following claims are intended to cover allsuch modification and variations.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more embodiments has been presented for purposes ofillustration and description. It is not intended to be exhaustive orlimiting to the precise form disclosed. Modifications or variations arepossible in light of the above teachings. The one or more embodimentswere chosen and described in order to illustrate principles andpractical application to thereby enable one of ordinary skill in the artto utilize the various embodiments and with various modifications as aresuited to the particular use contemplated. It is intended that theclaims submitted herewith define the overall scope.

Various aspects of the subject matter described herein are set out inthe following numbered clauses:

1. An ultrasonic surgical instrument, comprising: a waveguide comprisinga proximal end and a distal end, wherein the proximal end is coupled toan ultrasonic transducer; a tube defining a lumen, wherein the waveguideis located within the lumen; an end effector coupled to the distal endof the waveguide, the end effector comprising an ultrasonic blade and aclamp arm operatively coupled to the end effector; and a tissueaccumulation impedance mechanism coupled to the end effector, whereinthe tissue accumulation impedance mechanism is configured to preventtissue from accumulating within the lumen.

2. The surgical instrument of clause 1, wherein the tissue accumulationimpedance mechanism comprises a boot barrier configured to create a sealbetween the tube and the end effector.

3. The surgical instrument of clause 2, wherein the boot barrier issealed to the tube

4. The surgical instrument of clause 2, wherein the boot is retained bythe tube or end effector using one or more retention features.

5. The surgical instrument of clause 2, wherein the boot barrier issealed to the ultrasonic blade by way of an interference fit between theboot barrier and the ultrasonic blade.

6. The surgical instrument of clause 2, wherein the boot barriercomprises a cavity.

7. The surgical instrument of clause 6, wherein the cavity is rounded toallow fluid to flow out of the cavity.

8. The surgical instrument of clause 2, wherein the boot barriercomprises a plurality of contact points with the blade.

9. The surgical instrument of claim 1, wherein the tissue accumulationimpedance mechanism comprises one or more apertures in the tube.

10. The surgical instrument of claim 9, wherein the apertures compriseone or more windows.

11. The surgical instrument of claim 9, wherein the apertures comprisesone or more holes.

12. The surgical instrument of claim 1, wherein the tube comprises adistal portion, wherein the distal portion comprises a half-circle crosssection.

13. The surgical instrument of claim 1, wherein the tube comprises oneor more ribs formed on an inner side of the tube.

14. The surgical instrument of claim 1, wherein the tissue accumulationimpedance mechanism comprises a pump configured to provide a positivepressure flow between the blade and the tube, wherein the positivepressure flow prevents tissue ingress into the lumen.

15. The surgical instrument of claim 1, wherein the pump is locateddistally to a distal-most overmolded seal located within the lumen.

16. The surgical instrument of claim 1, wherein the tissue accumulationimpedance mechanism comprises a slidable tube disposed within the lumen,the slidable tube slidable from a first position to a second position,wherein in the first position the slidable tube is disposed over theblade, and wherein in the second position the blade is exposed.

17. An ultrasonic surgical instrument comprising: z waveguide comprisinga proximal end and a distal end, wherein the proximal end is coupled toa transducer; an end effector coupled to the distal end of thewaveguide, the end effector comprising at least one tissue retentionfeature; a clamp arm operatively coupled to the end effector.

18. The surgical instrument of claim 17, wherein the at least one tissueretention feature comprises one or more indentations/grooves/notchesformed in the end effector.

19. The surgical instrument of claim 18, wherein the one or moreindentations comprise triangular teeth.

20. The surgical instrument of claim 18, wherein the one or moreindentations comprise holes.

21. The surgical instrument of claim 18, wherein the one or moreindentations comprise horizontal trenches.

22. The surgical instrument of claim 17, wherein the at least one tissueretention feature is offset from the tissue dividing crown of the endeffector.

23. The surgical instrument of claim 17, wherein the at least on tissueretention feature comprises one or more projections from the endeffector.

24. The surgical instrument of claim 23, wherein the one or moreprojections comprise triangular teeth.

25. The surgical instrument of claim 23, wherein the one or moreprojections comprise blocks.

26. The surgical instrument of claim 23, wherein the one or moreprojections comprise horizontal bumps.

27. The surgical instrument of claim 23, wherein the one or moreprojections comprise circular bumps.

28. The surgical instrument of claim 17, wherein the at least one tissueretention feature is disposed over an entire length of the blade.

29. The surgical instrument of claim 17, wherein the at least one tissueretention feature is disposed over a discrete section of the blade.

30. An ultrasonic surgical instrument, comprising: a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to a transducer; an end effector operatively coupled to thedistal end of the waveguide guide; a rotation shroud configured torotate the waveguide; and a rotation stop mechanism coupled to therotation shroud prevent rotation of the rotation knob beyond apredetermined rotation.

31. The surgical instrument of claim 30, wherein the shroud comprises:at least one channel; and at least one boss, the at least one bosslocated within the at least one channel, wherein the at least one bosshas a predetermined lateral movement limit, wherein when the at leastone boss reaches the predetermined lateral movement limit, the at leastone boss prevents further rotation of the rotation knob.

32. The surgical instrument of claim 30, wherein the rotation stopcomprises: a gate comprising a first wing and a second wing, wherein thefirst and second wings are disposed at an angle, wherein the gate isdisposed within the shroud, and wherein the gate allows a predeterminedangle of rotation of the shroud.

33. The surgical instrument of claim 30, wherein the rotation stopcomprises a contoured extrusion element.

34. The surgical instrument of claim 33, wherein the contoured extrusionelement comprises a tactile feedback element.

35. The surgical instrument of claim 34, wherein the tactile feedbackelement comprises a semi-compliant material selected from the groupconsisting of rubber, medium to high density rubber, silicone,thermoplastic elastomer, springy piece of stainless steel, spring steel,copper, shape memory metal, and combinations of any thereof.

36. An ultrasonic surgical instrument, comprising: a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to a transducer; an end effector coupled to the distal end ofthe waveguide; a clamp arm operatively coupled to the end effector; anda tube disposed over the waveguide, wherein the tube comprises a counterdeflection element, wherein the counter deflection element is configuredto allow deflection of the blade, wherein the deflection of the bladecounteracts a force placed on the blade by the clamp arm when in aclamped position.

37. A surgical instrument comprising: a waveguide comprising a proximalend and a distal end, wherein the proximal end is coupled to a signalsource, the signal source configured to provide an ultrasonic signal andan electrosurgical signal; an end effector coupled to the waveguide; aclamp arm operatively coupled to the end effector; and a sealing button,wherein the sealing button causes the surgical instrument to deliver theelectrosurgical signal to the end effector and the clamp arm for a firstperiod, and wherein the sealing button causes the surgical instrument todeliver the ultrasonic signal to the blade for a second period, whereinthe second period is subsequent to the first period.

38. A surgical instrument, comprising: a waveguide comprising a proximalend and a distal end, wherein the proximal end is coupled to atransducer; an end effector coupled to the distal end of the waveguide;a tube disposed over the waveguide; a cam surface formed on an outersurface of the tube; and a clamp arm operatively coupled to the camsurface.

39. The surgical instrument of claim 38, comprising: a pivot pin locatedwithin a hole defined by the end effector, the pivot pin operativelycoupled to the clamp arm, wherein the clamp arm pivots about the pivotpin.

40. The surgical instrument of claim 39, wherein the pivot pin islocated at the distal most node of the waveguide.

41. The surgical instrument of claim 38, wherein the tube is actuatable,and wherein the clamp arm is cammed open and closed against the endeffector through relative motion between the tube and the end effector.

42. A surgical instrument, comprising: a waveguide comprising a proximalend and a distal end, wherein the proximal end is coupled to atransducer; an end effector coupled to the distal end of the waveguide,the end effector defining a pin hole; a rigid pin disposed within thepin hole; a clamp arm; and a four-bar linkage; wherein the four-barlinkage is operatively coupled to the clamp arm and the rigid pin,wherein the four-bar linkage is actuatable to move the clamp arm to aclamped position.

43. The surgical instrument of claim 40, comprising: an outer tube,wherein the outer tube is coupled to the four-bar linkage, and whereinthe outer-tube actuates the four-bar linkage from a first position to asecond position.

44. An ultrasonic surgical instrument, comprising: a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to a transducer; and an end effector coupled to the distal endof the waveguide, wherein the end effector is partially coated withthermally and electrically insulative material such that the distal endof the end effector comprises one or more exposed sections.

45. The ultrasonic surgical instrument of claim 44, wherein the one ormore exposed areas are symmetrical.

46. The ultrasonic surgical instrument of claim 44, wherein the one ormore exposed areas are asymmetrical.

47. The ultrasonic surgical instrument of claim 44, wherein the one ormore exposed sections are separated by one or more coated sections.

48. The ultrasonic surgical instrument of claim 44, wherein thewaveguide is fully coated with thermally and electrically insulativematerial.

49. The ultrasonic surgical instrument of claim 44, wherein thewaveguide is partially coated with thermally and electrically insulativematerial.

50. An ultrasonic surgical instrument, comprising: a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to a transducer; and an end effector coupled to the distal endof the waveguide, a clamp arm operatively connected to the end effectorwherein the clamp arm is partially coated with thermally andelectrically insulative material such that the distal end of the clamparm comprises one or more exposed sections.

51. The ultrasonic surgical instrument of claim 50, wherein the one ormore exposed areas are symmetrical.

52. The ultrasonic surgical instrument of claim 50, wherein the one ormore exposed areas are asymmetrical.

53. The ultrasonic surgical instrument of claim 50, wherein the one ormore exposed sections are separated by one or more coated sections.

54. The ultrasonic surgical instrument of claim 50, wherein thewaveguide is fully coated with thermally and electrically insulativematerial.

55. The ultrasonic surgical instrument of claim 50, wherein thewaveguide is fully coated with thermally and electrically insulativematerial.

56. An ultrasonic surgical instrument, comprising: a waveguidecomprising a proximal end and a distal end, wherein the proximal end iscoupled to a transducer; and an end effector coupled to the distal endof the waveguide, a clamp arm operatively connected to the end effectorwherein the clamp arm and the end effector are partially coated withthermally and electrically insulative material such that the distal endof the end effector and clamp arm comprise one or more exposed sections.

57. The ultrasonic surgical instrument of claim 56, wherein the one ormore exposed areas are symmetrical.

58. The ultrasonic surgical instrument of claim 56, wherein the one ormore exposed areas are asymmetrical.

59. The ultrasonic surgical instrument of claim 56, wherein the one ormore exposed sections are separated by one or more coated sections.

60. The ultrasonic surgical instrument of claim 56, wherein thewaveguide is fully coated with thermally and electrically insulativematerial.

61. The ultrasonic surgical instrument of claim 56, wherein thewaveguide is fully coated with thermally and electrically insulativematerial.

62. An ultrasonic surgical instrument, comprising: ultrasonic endeffector comprising an ultrasonic surgical blade and a clamp arm; and aheat shield provided at a predetermined distance from the ultrasonicblade.

63. The ultrasonic instrument of claim 62, wherein the heat shield isrotatable about the ultrasonic blade.

64. The ultrasonic instrument of 62, comprising a heat sink.

65. The ultrasonic instrument of 62, wherein the heat shield comprises aplurality of apertures.

66. The ultrasonic instrument of 62, wherein the heat shield comprises atapered portion.

67. An integrated radio frequency (RF)/ultrasonic surgical instrument,comprising: an ultrasonic transducer; a jack connector electricallycoupled to the ultrasonic transducer; and a slidable female mating plugmatable with the jack connector; wherein the slidable female mating plugis slidable in multiple positions to electrically couple the ultrasonictransducer to either an ultrasonic energy source or an RF energy source.

68. The integrated radio frequency (RF)/ultrasonic surgical instrumentof claim 67, wherein the jack connector is rotatable with the ultrasonictransducer.

69. The integrated radio frequency (RF)/ultrasonic surgical instrumentof claim 67, wherein the jack connector is a four-lead jack connector.

70. The integrated radio frequency (RF)/ultrasonic surgical instrumentof claim 67, wherein the slidable female mating plug in slidable betweena first position and a second position; wherein in the first positionthe ultrasonic transducer is electrically coupled to the ultrasonicenergy source and is electrically isolated from the RF energy source;and wherein in the second position the ultrasonic transducer iselectrically coupled to the RF energy source and is electricallyisolated from the ultrasonic energy source.

71. An ultrasonic energy driven rongeur device, comprising: at least oneelongate member; a linkage connected to a distal end of the at least oneelongate member; an ultrasonic transducer coupled to the at least oneelongate member; and a pivot located at an ultrasonic node of the atleast one elongate member.

72. The ultrasonic energy driven rongeur device of claim 71, comprising:a second linkage connected to a proximal end of the at least oneelongate member; and a second pivot located at a second ultrasonic ofthe at least one elongate member.

73. The ultrasonic energy driven rongeur device of claim 71, comprising:a second elongate member above the at least one elongate member; and adamping material disposed between the least one elongate member and thesecond elongate member.

1. A surgical instrument, comprising: an ultrasonic waveguide comprisinga proximal end and a distal end, wherein the proximal end is configuredto couple to an ultrasonic transducer; a first tube defining a lumen,wherein the waveguide is located within the lumen; an end effectorcoupled to the distal end of the waveguide, the end effector comprisingan ultrasonic blade and a clamp arm, the clamp arm movable from aclamped position to a non-clamped position; and an impedance mechanismoperatively coupled to the end effector to prevent materials fromaccumulating within the lumen during a surgical procedure.
 2. Thesurgical instrument of claim 1, wherein the impedance mechanismcomprises a boot seal to create a barrier between the first tube and theend effector.
 3. The surgical instrument of claim 2, wherein the bootseal is sealed to the first tube.
 4. The surgical instrument of claim 2,wherein the first tube or the end effector comprises at least oneretention feature to retain the boot seal.
 5. The surgical instrument ofclaim 2, further comprising an interference fit provided between theboot seal and the ultrasonic blade to seal the boot seal to theultrasonic blade.
 6. The surgical instrument of claim 2, wherein theboot seal comprises a cavity.
 7. The instrument of claim 6, wherein thecavity is rounded to allow fluid to flow out of the cavity.
 8. Thesurgical instrument of claim 2, wherein the boot seal comprises aplurality of contact points in contact with the blade.
 9. A surgicalinstrument, comprising: an ultrasonic waveguide comprising a proximalend and a distal end, wherein the proximal end is configured to coupleto an ultrasonic transducer; a first tube defining a lumen, wherein thewaveguide is located within the lumen, the first tube comprising atleast one aperture to prevent materials from accumulating within thelumen during a surgical procedure; and an end effector coupled to thedistal end of the waveguide, the end effector comprising an ultrasonicblade and a clamp arm, the clamp arm movable from a clamped position toa non-clamped position.
 10. The surgical instrument of claim 9, whereinthe at least one aperture in the first tube comprises at least onewindow.
 11. The surgical instrument of claim 9, wherein the at least oneaperture in the first tube comprises at least one hole.
 12. The surgicalinstrument of claim 9, wherein the first tube comprises a half-circlecross sectional portion at a distal end thereof.
 13. The surgicalinstrument of claim 9, wherein the first tube comprises at least one ribformed on an inner side of the first tube.
 14. The surgical instrumentof claim 9, further comprising a second tube disposed within the lumenof the first tube, wherein the second tube is slidable from a firstposition to a second position, wherein in the first position the bladeis disposed within the second tube, and wherein in the second positionthe blade is disposed outside the second tube.
 15. A surgicalinstrument, comprising: an ultrasonic waveguide comprising a proximalend and a distal end, wherein the proximal end is configured to coupleto an ultrasonic transducer; a first tube defining a lumen, wherein thewaveguide is located within the lumen; a pump fluidically coupled to thefirst tube to apply a positive pressure between the blade and the firsttube to prevent materials from accumulating within the lumen during asurgical procedure; and an end effector coupled to the distal end of thewaveguide, the end effector comprising an ultrasonic blade and a clamparm, the clamp arm movable from a clamped position to a non-clampedposition.
 16. The surgical instrument of claim 15, the first tubecomprising at least one aperture to fluidically couple to the pump. 17.The surgical instrument of claim 16, wherein the pump is locatedproximal of a distal end of the first tube.
 18. The surgical instrumentof claim 17, wherein the pump is located distal of a distal node of thewaveguide.
 19. The surgical instrument of claim 15, wherein a distal endof the first tube comprises a flexible seal between the blade and thefirst tube, and wherein an outlet portion of the pump is locateddistally of the flexible seal.
 20. The surgical instrument of claim 15,wherein the pump is configured to operate with a fluid medium comprisingliquid or gas.